ALBUMIN

Bromcresol Green Dye-binding, Albumin

DILAB, INC.

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

Pre-market Notification Details

Device IDK850931
510k NumberK850931
Device Name:ALBUMIN
ClassificationBromcresol Green Dye-binding, Albumin
Applicant DILAB, INC. 7003 N.W. 50TH ST. Miami,  FL  33166
ContactRafael A Quevedo
CorrespondentRafael A Quevedo
DILAB, INC. 7003 N.W. 50TH ST. Miami,  FL  33166
Product CodeCIX  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1985-03-07
Decision Date1985-06-26

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