AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT

Radioimmunoassay, Luteinizing Hormone

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Luteinizing Hormone Radioimmuno-kit.

Pre-market Notification Details

Device IDK851104
510k NumberK851104
Device Name:AMERLEX-M LUTEINIZING HORMONE RADIOIMMUNO-KIT
ClassificationRadioimmunoassay, Luteinizing Hormone
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactPhilip M Frantasia
CorrespondentPhilip M Frantasia
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeCEP  
CFR Regulation Number862.1485 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-19
Decision Date1985-04-10

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