Device Classification Name |
radioimmunoassay, follicle-stimulating hormone
|
510(k) Number |
K964720 |
Device Name |
VITROS IMMUNODIAGNOSTICS PRODUCTS FSH REAGENT PACK (GEM. 1005) FSH CALIBRATORS (GEM.C005) |
Applicant |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14650 -0882
|
|
Applicant Contact |
ANN M QUINN |
Correspondent |
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. |
100 INDIGO CREEK DR. |
ROCHESTER,
NY
14650 -0882
|
|
Correspondent Contact |
ANN M QUINN |
Regulation Number | 862.1300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/25/1996 |
Decision Date | 02/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|