CARESIDE ALBUMIN

Bromcresol Green Dye-binding, Albumin

EXIGENT DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK980041
510k NumberK980041
Device Name:CARESIDE ALBUMIN
ClassificationBromcresol Green Dye-binding, Albumin
Applicant EXIGENT DIAGNOSTICS, INC. 6100 BRISTOL PKWY. Culver City,  CA  90230
ContactKenneth B Asarch
CorrespondentKenneth B Asarch
EXIGENT DIAGNOSTICS, INC. 6100 BRISTOL PKWY. Culver City,  CA  90230
Product CodeCIX  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-06
Decision Date1998-02-04
Summary:summary

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