HARDYDISK BACITRACIN, 10MCG, MODEL Z927

Susceptibility Test Discs, Antimicrobial

HARDY DIAGNOSTICS

The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Bacitracin, 10mcg, Model Z927.

Pre-market Notification Details

Device IDK011086
510k NumberK011086
Device Name:HARDYDISK BACITRACIN, 10MCG, MODEL Z927
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 Received2001-04-10
Decision Date2001-04-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816576021093 K011086 000
00816576028290 K011086 000

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