AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST

Radioimmunoassay, Luteinizing Hormone

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Lh-30 Assay, Lan.0082/2082 240/144 Test.

Pre-market Notification Details

Device IDK880933
510k NumberK880933
Device Name:AMERLITE LH-30 ASSAY, LAN.0082/2082 240/144 TEST
ClassificationRadioimmunoassay, Luteinizing Hormone
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactJan L Zorn
CorrespondentJan L Zorn
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 Received1988-03-07
Decision Date1988-07-28

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