CARDIAC STATUS CONTROLS

Enzyme Controls (assayed And Unassayed)

SPECTRAL DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Spectral Diagnostics, Inc. with the FDA for Cardiac Status Controls.

Pre-market Notification Details

Device IDK972408
510k NumberK972408
Device Name:CARDIAC STATUS CONTROLS
ClassificationEnzyme Controls (assayed And Unassayed)
Applicant SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario,  CA M9c1c2
ContactFrancee S Boches
CorrespondentFrancee S Boches
SPECTRAL DIAGNOSTICS, INC. 135-2 THE WEST MALL Toronto, Ontario,  CA M9c1c2
Product CodeJJT  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1997-06-26
Decision Date1997-07-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.