BIOTROL CALIBRANT LEVEL 3

Calibrator, Multi-analyte Mixture

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Calibrant Level 3.

Pre-market Notification Details

Device IDK875318
510k NumberK875318
Device Name:BIOTROL CALIBRANT LEVEL 3
ClassificationCalibrator, Multi-analyte Mixture
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 CodeJIX  
CFR Regulation Number862.1150 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-12-29
Decision Date1988-02-02

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