HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883

Susceptibility Test Discs, Antimicrobial

HARDY DIAGNOSTICS

The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Novobiocin, 30mcg, Model Z883.

Pre-market Notification Details

Device IDK011384
510k NumberK011384
Device Name:HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria,  CA  93455
ContactMelissa M Traylor, Rac
CorrespondentMelissa M Traylor, Rac
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 Received2001-05-07
Decision Date2001-06-13

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816576020836 K011384 000
00816576020829 K011384 000

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