BIOTROL BILIRUBIN MONOREACTIF

Cresolphthalein Complexone, Calcium

BIOTROL, USA, INC.

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

Pre-market Notification Details

Device IDK884480
510k NumberK884480
Device Name:BIOTROL BILIRUBIN MONOREACTIF
ClassificationCresolphthalein Complexone, Calcium
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 CodeCIC  
CFR Regulation Number862.1145 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-10-25
Decision Date1988-11-29

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