BIOTROL URIC ACID ENZYMATIQUE UV H.P.

Acid, Uric, Uricase (u.v.)

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Uric Acid Enzymatique Uv H.p..

Pre-market Notification Details

Device IDK875320
510k NumberK875320
Device Name:BIOTROL URIC ACID ENZYMATIQUE UV H.P.
ClassificationAcid, Uric, Uricase (u.v.)
Applicant BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern,  PA  19355
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. 5 GREAT VALLEY PKWY, SUITE 248 GREAT VALLEY CORP. CENTER Malvern,  PA  19355
Product CodeCDO  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-29
Decision Date1988-02-01

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