BIOTROL RUB-E.I.A. TEST G

Enzyme Linked Immunoabsorbent Assay, Rubella

BIOTROL, USA, INC.

The following data is part of a premarket notification filed by Biotrol, Usa, Inc. with the FDA for Biotrol Rub-e.i.a. Test G.

Pre-market Notification Details

Device IDK894544
510k NumberK894544
Device Name:BIOTROL RUB-E.I.A. TEST G
ClassificationEnzyme Linked Immunoabsorbent Assay, Rubella
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 CodeLFX  
CFR Regulation Number866.3510 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1989-07-20
Decision Date1989-08-30

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