Device Classification Name |
Calibrator, Primary
|
510(k) Number |
K022901 |
Device Name |
VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTERONE REAGENT PACK AND CALIBRATORS |
Applicant |
ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14626 -5101
|
|
Applicant Contact |
MARLENE HANNA |
Correspondent |
ORTHO-CLINICAL DIAGNOSTICS |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14626 -5101
|
|
Correspondent Contact |
MARLENE HANNA |
Regulation Number | 862.1150
|
Classification Product Code |
|
Date Received | 09/03/2002 |
Decision Date | 09/27/2002 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|