SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST

Chromatographic Separation, Cpk Isoenzymes

SPECTRAL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Spectral Diagnostics, Inc. with the FDA for Spectral's Cardiac Status Ck-mb Rapid Test.

Pre-market Notification Details

Device IDK022409
510k NumberK022409
Device Name:SPECTRAL'S CARDIAC STATUS CK-MB RAPID TEST
ClassificationChromatographic Separation, Cpk Isoenzymes
Applicant SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario,  CA M9c1c2
ContactNisar A Shaikh
CorrespondentNisar A Shaikh
SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario,  CA M9c1c2
Product CodeJHT  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2002-07-24
Decision Date2002-09-30

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