BIOTROL-33 PLUS ASSAYED CHEMISTRY 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 Biotrol-33 Plus Assayed Chemistry Control Serum.

Pre-market Notification Details

Device IDK872785
510k NumberK872785
Device Name:BIOTROL-33 PLUS ASSAYED CHEMISTRY CONTROL SERUM
ClassificationMulti-analyte Controls, All Kinds (assayed)
Applicant BIOTROL, USA, INC. P.O. BOX 562 Berwyn,  PA  19312
ContactAllan C Murphy
CorrespondentAllan C Murphy
BIOTROL, USA, INC. P.O. BOX 562 Berwyn,  PA  19312
Product CodeJJY  
CFR Regulation Number862.1660 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1987-07-14
Decision Date1987-08-26

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