BIOTROL CREATININE H.P. REAGENT

Alkaline Picrate, Colorimetry, Creatinine

BIOTROL, USA, INC.

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

Pre-market Notification Details

Device IDK881856
510k NumberK881856
Device Name:BIOTROL CREATININE H.P. REAGENT
ClassificationAlkaline Picrate, Colorimetry, Creatinine
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 CodeCGX  
CFR Regulation Number862.1225 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1988-05-03
Decision Date1988-06-16

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.