IN-VITRO TEST DETERMINATION OF ALBUMIN

Bromcresol Green Dye-binding, Albumin

CLINICAL DATA, INC.

The following data is part of a premarket notification filed by Clinical Data, Inc. with the FDA for In-vitro Test Determination Of Albumin.

Pre-market Notification Details

Device IDK854181
510k NumberK854181
Device Name:IN-VITRO TEST DETERMINATION OF ALBUMIN
ClassificationBromcresol Green Dye-binding, Albumin
Applicant CLINICAL DATA, INC. 1172 COMMONWEALTH AVE. Boston,  MA  02134
ContactIsrael M Stein
CorrespondentIsrael M Stein
CLINICAL DATA, INC. 1172 COMMONWEALTH AVE. Boston,  MA  02134
Product CodeCIX  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-10-15
Decision Date1985-11-25

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.