CARESIDE CALCIUM, ORIGINAL

Azo Dye, Calcium

CARESIDE, INC.

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

Pre-market Notification Details

Device IDK983789
510k NumberK983789
Device Name:CARESIDE CALCIUM, ORIGINAL
ClassificationAzo Dye, Calcium
Applicant CARESIDE, INC. 6100 BRISTOL PKWY. Culver City,  CA  90230
ContactKenneth B Asarch Pharm
CorrespondentKenneth B Asarch Pharm
CARESIDE, INC. 6100 BRISTOL PKWY. Culver City,  CA  90230
Product CodeCJY  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-10-27
Decision Date1998-12-17
Summary:summary

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