BIOTROL URINE PROTEINS REAGENT

Indicator Method, Protein Or Albumin (urinary, Non-quant.)

BIOTROL, USA, INC.

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

Pre-market Notification Details

Device IDK885053
510k NumberK885053
Device Name:BIOTROL URINE PROTEINS REAGENT
ClassificationIndicator Method, Protein Or Albumin (urinary, Non-quant.)
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 CodeJIR  
CFR Regulation Number862.1645 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-12-07
Decision Date1989-01-30

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