VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)

System, Test, Human Chorionic Gonadotropin

JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC.

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).

Pre-market Notification Details

Device IDK970894
510k NumberK970894
Device Name:VITROS IMMUNODIAGNOSTICS PRODUCTS TOTAL B-HCG REAGENT PACK (GEM.1075), TOTAL B-HCG CALIBRATORS (GEM.C075)
ClassificationSystem, Test, Human Chorionic Gonadotropin
Applicant JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
ContactAnn M Quinn
CorrespondentAnn M Quinn
JOHNSON & JOHNSON CLINICAL DIAGNOSTICS, INC. 100 INDIGO CREEK DR. Rochester,  NY  14650 -0882
Product CodeDHA  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-03-11
Decision Date1997-04-14

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.