AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)

Radioimmunoassay, Prolactin (lactogen)

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Prolactin Assay, Lan.0078/2078(240/144).

Pre-market Notification Details

Device IDK883878
510k NumberK883878
Device Name:AMERLITE PROLACTIN ASSAY, LAN.0078/2078(240/144)
ClassificationRadioimmunoassay, Prolactin (lactogen)
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 CodeCFT  
CFR Regulation Number862.1625 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-09-13
Decision Date1988-11-01

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