CARESIDE CKMB

Differential Rate Kinetic Method, Cpk Or Isoenzymes

CARESIDE, INC.

The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Ckmb.

Pre-market Notification Details

Device IDK990434
510k NumberK990434
Device Name:CARESIDE CKMB
ClassificationDifferential Rate Kinetic Method, Cpk Or Isoenzymes
Applicant CARESIDE, INC. 6100 BRISTOL PKWY. Culver City,  CA  90230
ContactKenneth B Asarch
CorrespondentKenneth B Asarch
CARESIDE, INC. 6100 BRISTOL PKWY. Culver City,  CA  90230
Product CodeJHS  
CFR Regulation Number862.1215 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-02-11
Decision Date1999-04-19
Summary:summary

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