MIDSTREAM HOME REGNANCY TEST

System, Test, Human Chorionic Gonadotropin

GERMAINE LABORATORIES, INC.

The following data is part of a premarket notification filed by Germaine Laboratories, Inc. with the FDA for Midstream Home Regnancy Test.

Pre-market Notification Details

Device IDK973825
510k NumberK973825
Device Name:MIDSTREAM HOME REGNANCY TEST
ClassificationSystem, Test, Human Chorionic Gonadotropin
Applicant GERMAINE LABORATORIES, INC. 4203 GARDENDALE CENTER, #230 San Antonio,  TX  78229
ContactMartin O'connor
CorrespondentMartin O'connor
GERMAINE LABORATORIES, INC. 4203 GARDENDALE CENTER, #230 San Antonio,  TX  78229
Product CodeDHA  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-10-07
Decision Date1997-12-19
Summary:summary

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