BIOTROL TOTAL PROTEIN H.P.

Biuret (colorimetric), Total Protein

BIOTROL, USA, INC.

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

Pre-market Notification Details

Device IDK882189
510k NumberK882189
Device Name:BIOTROL TOTAL PROTEIN H.P.
ClassificationBiuret (colorimetric), Total Protein
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 CodeCEK  
CFR Regulation Number862.1635 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-24
Decision Date1988-07-01

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