The following data is part of a premarket notification filed by Johnson & Johnson Clinical Diagnostics, Inc. with the FDA for Vitros Immunodiagnostics Products Total B-hcg Reagent Pack (gem.1075), Total B-hcg Calibrators (gem.c075).
Device ID | K970894 |
510k Number | K970894 |
Device Name: | VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075) |
Classification | System, Test, Human Chorionic Gonadotropin |
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 | DHA |
CFR Regulation Number | 862.1155 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1997-03-11 |
Decision Date | 1997-04-14 |