HARDYDISK, KANAMYCIN, 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, Kanamycin, 30mcg.

Pre-market Notification Details

Device IDK000203
510k NumberK000203
Device Name:HARDYDISK, KANAMYCIN, 30MCG
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria,  CA  93455
ContactMelissa Traylor
CorrespondentMelissa 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 Received2000-01-21
Decision Date2000-03-21

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816576020737 K000203 000
00816576020720 K000203 000

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