BIOTROL BILIRUBIN C & T CONTROL

Single (specified) Analyte Controls (assayed And Unassayed)

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Bilirubin C & T Control.

Pre-market Notification Details

Device IDK905280
510k NumberK905280
Device Name:BIOTROL BILIRUBIN C & T CONTROL
ClassificationSingle (specified) Analyte Controls (assayed And Unassayed)
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 CodeJJX  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1990-11-23
Decision Date1991-02-04

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