AMERLITE CK-MB ASSAY

Colorimetric Method, Cpk Or Isoenzymes

AMERSHAM CORP.

The following data is part of a premarket notification filed by Amersham Corp. with the FDA for Amerlite Ck-mb Assay.

Pre-market Notification Details

Device IDK912766
510k NumberK912766
Device Name:AMERLITE CK-MB ASSAY
ClassificationColorimetric Method, Cpk Or Isoenzymes
Applicant AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
ContactKathryn Patterson
CorrespondentKathryn Patterson
AMERSHAM CORP. 2636 SOUTH CLEARBROOK DR. Arlington Heights,  IL  60005
Product CodeJHY  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-06-24
Decision Date1991-07-17

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