GENESIS B-HCG

Visual, Pregnancy Hcg, Prescription Use

ARMKEL, LLC.

The following data is part of a premarket notification filed by Armkel, Llc. with the FDA for Genesis B-hcg.

Pre-market Notification Details

Device IDK823753
510k NumberK823753
Device Name:GENESIS B-HCG
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant ARMKEL, LLC. 803 N. Front St. Suite 3 Mchenry,  IL  60050
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1982-12-14
Decision Date1983-01-24

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