CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC

Susceptibility Test Discs, Antimicrobial

UNIPATH LTD.

The following data is part of a premarket notification filed by Unipath Ltd. with the FDA for Cefepine Antimicrobial Susceptibility Test Disc.

Pre-market Notification Details

Device IDK964495
510k NumberK964495
Device Name:CEFEPINE ANTIMICROBIAL SUSCEPTIBILITY TEST DISC
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant UNIPATH LTD. 15 OAK ST. Beverly Farms,  MA  01915
ContactFran White
CorrespondentFran White
UNIPATH LTD. 15 OAK ST. Beverly Farms,  MA  01915
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1996-11-08
Decision Date1997-02-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
05032384006991 K964495 000

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