Device Classification Name |
multi-analyte controls, all kinds (assayed)
|
510(k) Number |
K973030 |
Device Name |
VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) |
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 | 862.1660
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 08/14/1997 |
Decision Date | 09/04/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Clinical Chemistry
|
510k Review Panel |
Clinical Chemistry
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|