HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG

Susceptibility Test Discs, Antimicrobial

HARDY DIAGNOSTICS

The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Amoxicillin/clavulanic Acid, 20/10mcg.

Pre-market Notification Details

Device IDK003556
510k NumberK003556
Device Name:HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG
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 Received2000-11-17
Decision Date2001-01-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816576020324 K003556 000
00816576020317 K003556 000

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