CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)

Multi-analyte Controls, All Kinds (assayed)

SPECTRAL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Spectral Diagnostics, Inc. with the FDA for Cardiac Status Controls (ck-mb/myoglobin/troponin I).

Pre-market Notification Details

Device IDK981474
510k NumberK981474
Device Name:CARDIAC STATUS CONTROLS (CK-MB/MYOGLOBIN/TROPONIN I)
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario,  CA M9c1c2
ContactJoseph Laurino
CorrespondentJoseph Laurino
SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario,  CA M9c1c2
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-04-24
Decision Date1998-05-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
B103CSC30231 K981474 000

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