HARDYDISK, STREPTOMYCIN 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, Streptomycin 10mcg.

Pre-market Notification Details

Device IDK000201
510k NumberK000201
Device Name:HARDYDISK, STREPTOMYCIN 10MCG
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 Date2000-02-29

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816576020959 K000201 000
00816576020942 K000201 000

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