CARESIDE BUN

Urease And Glutamic Dehydrogenase, Urea Nitrogen

EXIGENT DIAGNOSTICS, INC.

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

Pre-market Notification Details

Device IDK980057
510k NumberK980057
Device Name:CARESIDE BUN
ClassificationUrease And Glutamic Dehydrogenase, Urea Nitrogen
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 CodeCDQ  
CFR Regulation Number862.1770 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-01-06
Decision Date1998-02-05
Summary:summary

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