EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS

Enzyme Immunoassay, Gentamicin

BEHRING DIAGNOSTICS, INC.

The following data is part of a premarket notification filed by Behring Diagnostics, Inc. with the FDA for Emit 2000 Gentamicin Assay And Calibrators.

Pre-market Notification Details

Device IDK962519
510k NumberK962519
Device Name:EMIT 2000 GENTAMICIN ASSAY AND CALIBRATORS
ClassificationEnzyme Immunoassay, Gentamicin
Applicant BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose,  CA  95161 -9013
ContactPaul L Rogers
CorrespondentPaul L Rogers
BEHRING DIAGNOSTICS, INC. 3403 YERBA BUENA RD. P.O. BOX 49013 San Jose,  CA  95161 -9013
Product CodeLCD  
CFR Regulation Number862.3450 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-06-27
Decision Date1996-09-04
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00630414561943 K962519 000
00842768001093 K962519 000
00842768001086 K962519 000

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