Device Classification Name |
Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
|
510(k) Number |
K964721 |
Device Name |
VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL T4 REAGENT PACK (GEM.1005) TOTAL T4 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 | 862.1700
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 11/25/1996 |
Decision Date | 12/18/1996 |
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
|
|
|