Device Classification Name |
immunoassay method, troponin subunit
|
510(k) Number |
K024193 |
Device Name |
MODIFICATION TO VITROS IMMUNDODIAGNOSTIC PRODUCTS TROPONIN I REAGENT PACK/CALIBRATORS |
Applicant |
ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14626 -5101
|
|
Applicant Contact |
ANN M QUINN |
Correspondent |
ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14626 -5101
|
|
Correspondent Contact |
ANN M QUINN |
Regulation Number | 862.1215
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 12/20/2002 |
Decision Date | 02/21/2003 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|