AMERLEX B-LCG RIA KIT

Visual, Pregnancy Hcg, Prescription Use

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex B-lcg Ria Kit.

Pre-market Notification Details

Device IDK821031
510k NumberK821031
Device Name:AMERLEX B-LCG RIA KIT
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant AMERSHAM CORP. 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 Received1982-04-13
Decision Date1982-05-03

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