CARESIDE CO2, TOTAL

Enzymatic, Carbon-dioxide

CARESIDE, INC.

The following data is part of a premarket notification filed by Careside, Inc. with the FDA for Careside Co2, Total.

Pre-market Notification Details

Device IDK992475
510k NumberK992475
Device Name:CARESIDE CO2, TOTAL
ClassificationEnzymatic, Carbon-dioxide
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 CodeKHS  
CFR Regulation Number862.1160 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1999-07-26
Decision Date1999-09-15
Summary:summary

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