CARDIAC T TROPONIN T RAPID ASSAY

Immunoassay Method, Troponin Subunit

BOEHRINGER MANNHEIM CORP.

The following data is part of a premarket notification filed by Boehringer Mannheim Corp. with the FDA for Cardiac T Troponin T Rapid Assay.

Pre-market Notification Details

Device IDK964372
510k NumberK964372
Device Name:CARDIAC T TROPONIN T RAPID ASSAY
ClassificationImmunoassay Method, Troponin Subunit
Applicant BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis,  IN  46250 -0457
ContactJohn D Stevens
CorrespondentJohn D Stevens
BOEHRINGER MANNHEIM CORP. 9115 HAGUE RD. Indianapolis,  IN  46250 -0457
Product CodeMMI  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-01
Decision Date1997-02-10
Summary:summary

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