AIMSTEP PREGNANCY

Visual, Pregnancy Hcg, Prescription Use

GERMAINE LABORATORIES, INC.

The following data is part of a premarket notification filed by Germaine Laboratories, Inc. with the FDA for Aimstep Pregnancy.

Pre-market Notification Details

Device IDK980531
510k NumberK980531
Device Name:AIMSTEP PREGNANCY
ClassificationVisual, Pregnancy Hcg, Prescription Use
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 CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-02-11
Decision Date1998-03-06
Summary:summary

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