AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)

Radioimmunoassay, Cyclic Amp

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlex-m Camp(125)assay System Rpa.508 (100 Kit).

Pre-market Notification Details

Device IDK860253
510k NumberK860253
Device Name:AMERLEX-M CAMP(125)ASSAY SYSTEM RPA.508 (100 KIT)
ClassificationRadioimmunoassay, Cyclic Amp
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactDennis W Henkelman
CorrespondentDennis W Henkelman
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeCHO  
CFR Regulation Number862.1230 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-01-24
Decision Date1986-03-14

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