BIOTROL PROTEIN MULTILEVEL STANDARDS

Calibrator, Primary

BIOTROL, USA, INC.

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

Pre-market Notification Details

Device IDK910721
510k NumberK910721
Device Name:BIOTROL PROTEIN MULTILEVEL STANDARDS
ClassificationCalibrator, Primary
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 CodeJIS  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1991-02-20
Decision Date1991-05-06

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