BIOTROL URIC ACID ENZYMATIQUE TRINDER

Acid, Uric, Uricase (colorimetric)

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 Trinder.

Pre-market Notification Details

Device IDK883428
510k NumberK883428
Device Name:BIOTROL URIC ACID ENZYMATIQUE TRINDER
ClassificationAcid, Uric, Uricase (colorimetric)
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 CodeKNK  
CFR Regulation Number862.1775 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-08-15
Decision Date1988-09-13

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