AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI 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-m B-human Chorionic Gonadtropin Radioi Kit.

Pre-market Notification Details

Device IDK852675
510k NumberK852675
Device Name:AMERLEX-M B-HUMAN CHORIONIC GONADTROPIN RADIOI KIT
ClassificationVisual, Pregnancy Hcg, Prescription Use
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactPhilip M Fantasia
CorrespondentPhilip M Fantasia
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeJHI  
CFR Regulation Number862.1155 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-06-24
Decision Date1985-07-22

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