REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM

Multi-analyte Controls, All Kinds (assayed)

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Reference High Level Assayed Chem. Control Serum.

Pre-market Notification Details

Device IDK874809
510k NumberK874809
Device Name:REFERENCE HIGH LEVEL ASSAYED CHEM. CONTROL SERUM
ClassificationMulti-analyte Controls, All Kinds (assayed)
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 CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-11-20
Decision Date1988-01-07

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