AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086

Radioimmunoassay, Prolactin (lactogen)

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite(tm) Prolactin-30 Assay, Lan.0086/2086.

Pre-market Notification Details

Device IDK914135
510k NumberK914135
Device Name:AMERLITE(TM) PROLACTIN-30 ASSAY, LAN.0086/2086
ClassificationRadioimmunoassay, Prolactin (lactogen)
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactKathryn B Patterson
CorrespondentKathryn B Patterson
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeCFT  
CFR Regulation Number862.1625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-09-16
Decision Date1992-02-18

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