HARDYDISK, VANCOMYCIN 30MCG

Susceptibility Test Discs, Antimicrobial

HARDY DIAGNOSTICS

The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk, Vancomycin 30mcg.

Pre-market Notification Details

Device IDK000509
510k NumberK000509
Device Name:HARDYDISK, VANCOMYCIN 30MCG
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria,  CA  93455
ContactMelissa M Traylor
CorrespondentMelissa M Traylor
HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria,  CA  93455
Product CodeJTN  
CFR Regulation Number866.1620 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2000-02-15
Decision Date2000-04-07

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816576021086 K000509 000
00816576021079 K000509 000

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