SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST

Immunoassay Method, Troponin Subunit

SPECTRAL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Spectral Diagnostics, Inc. with the FDA for Spectral Cardiac Status Ck-mb/myoglobin/troponin I 3-in-1 Test.

Pre-market Notification Details

Device IDK030057
510k NumberK030057
Device Name:SPECTRAL CARDIAC STATUS CK-MB/MYOGLOBIN/TROPONIN I 3-IN-1 TEST
ClassificationImmunoassay Method, Troponin Subunit
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 CodeMMI  
Subsequent Product CodeDDR
Subsequent Product CodeJHT
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-01-07
Decision Date2003-03-19

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