The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostics Products/ck-mb Reagent Pack(gem.1300)/ck-mb Calibrators (gem.c300).
Device ID | K973030 |
510k Number | K973030 |
Device Name: | VITROS IMMUNODIAGNOSTICS PRODUCTS/CK-MB REAGENT PACK(GEM.1300)/CK-MB CALIBRATORS (GEM.C300) |
Classification | Multi-analyte Controls, All Kinds (assayed) |
Applicant | JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
Contact | Ann M Quinn |
Correspondent | Ann M Quinn JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester, NY 14650 -0882 |
Product Code | JJY |
Subsequent Product Code | JHX |
Subsequent Product Code | JIX |
CFR Regulation Number | 862.1660 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-08-14 |
Decision Date | 1997-09-04 |