Premarket Reviews |
Manufacturer | Decision |
AALTO SCIENTIFIC LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
AALTO SCIENTIFIC, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
ACON LABORATORIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
AMERICAN BIOLOGICAL TECHNOLOGIES, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
APEX BIO TECHNOLOGY CORP |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BAYER HEALTHCARE |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BECKMAN COULTER, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIO-RAD LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIONIME CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
BIONOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
8
|
CLINIQA CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
CONE BIOPRODUCTS |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
DIASORIN INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DIASORIN, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
DIAZYME LABORATORIES |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
FUJIREBIO DIAGNOSTICS, INC |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
FUJIREBIO DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
3
|
IMMUNODIAGNOSTIC SYSTEMS LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
MAINE STANDARDS CO. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
MAINE STANDARDS COMPANY LLC |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
MICROGENICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
QUANTIMETRIX CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
2
|
QUANTIMETRIX CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
RANDOX LABORATORIES, LTD. |
|
SUBSTANTIALLY EQUIVALENT
|
4
|
ROCHE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
33
|
1. K083655 ELECSYS TOXO IGG CALCHECK
|
2. K090311 ELECSYS RUBELLA IGG CALCHECK
|
3. K092168 ELECSYS HCG+B CALCHECK 5
|
4. K092169 ELECSYS PROBNP II CALCHECK 5
|
5. K092585 ELECSYS RUBELLA IGGA CALCHECK 5
|
6. K093582 ELECSYS CK-MB CALCHECK 5
|
7. K093836 ELECSYS TSH CALCHECK 5
|
8. K094031 ELECSYS FOLATE III CALCHECK 5
|
9. K100594 ELECSYS TROPONIN I CALCHECK 5
|
10. K100810 ELECSYS C-PEPTIDE CALCHECK 5
|
11. K101856 ELECSYS CEA CALCHECK 5
|
12. K102044 ELECSYS DIGOXIN CALCHECK 5
|
13. K102086 ELECSYS CA 125 II CALCHECK 5
|
14. K102267 ELECSYS FERRITIN CALCHECK 5
|
15. K102269 ELECSYS IGE CALCHECK 5
|
16. K103099 PRECICONTROL HBA1C NORM; PRECICONTROL HBA1C PATH
|
17. K103162 ELECSYS PTH CALCHECK 5
|
18. K103402 ELECSYS DHEA-S CALCHECK 5
|
19. K110613 ELECSYS PROLACTIN II CALCHECK 5
|
20. K111349 ELECSYS SHBG CALCHECK 5
|
21. K111552 ELECSYS T3 CALCHECK 5
|
22. K112104 ELECSYS N-MID OSTEOCALCIN CALCHECK 5
|
23. K112113 ELECSYS MYOGLOBIN CALCHECK 5
|
24. K121279 ELECSYS LH CALCHECK 5
|
25. K121895 ELECSYS HSV-2 IGG IMMUNOASSAY
|
26. K122242 ELECSYS CA 15-3 II CALCHECK 5
|
27. K133284 ELECSYS CK-MB CALCHECK 5
|
28. K140534 ELECSYS PRECICONTROL TS
|
29. K142127 ELECSYS ESTRADIOL III CALCHECK 5
|
30. K143284 Elecsys Estradiol III Calcheck
|
31. K150955 Elecsys Progesterone III Cal Check 5
|
32. K162173 Elecsys CYFRA 21-1 CalCheck 5
|
33. K170678 Beta-CrossLaps CalCheck 5
|
ROCHE DIAGNOSTICS CORP. |
|
SUBSTANTIALLY EQUIVALENT
|
6
|
ROCHE DIAGNOSTICS CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
SIEMENS HEALTHCARE DIAGNOSTICS |
|
SUBSTANTIALLY EQUIVALENT
|
7
|
SIEMENS HEALTHCARE DIAGNOSTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
16
|
SIEMENS HEALTHCARE DIAGNOSTICS, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
11
|
SIEMENS HELATHCARE DIAGNOSTICS INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TAIDOC TECHNOLOGY CORPORATION |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TECHNOPATH MANUFACTURING |
|
SUBSTANTIALLY EQUIVALENT
|
1
|
TOSOH BIOSCIENCE, INC. |
|
SUBSTANTIALLY EQUIVALENT
|
1
|