AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST

Radioimmunoassay, Follicle-stimulating Hormone

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Fsh Assay, Lan.0077/2077 240 And 144 Test.

Pre-market Notification Details

Device IDK881142
510k NumberK881142
Device Name:AMERLITE FSH ASSAY, LAN.0077/2077 240 AND 144 TEST
ClassificationRadioimmunoassay, Follicle-stimulating Hormone
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactFrank J Lyman
CorrespondentFrank J Lyman
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeCGJ  
CFR Regulation Number862.1300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-03-17
Decision Date1988-07-21

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