BIOTROL ALBUMIN

Bromcresol Green Dye-binding, Albumin

BIOTROL, USA, INC.

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

Pre-market Notification Details

Device IDK885094
510k NumberK885094
Device Name:BIOTROL ALBUMIN
ClassificationBromcresol Green Dye-binding, Albumin
Applicant BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester,  PA  19380
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. 113 BRANYWINE PKWY. Westchester,  PA  19380
Product CodeCIX  
CFR Regulation Number862.1035 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-09
Decision Date1989-02-10

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