HARDYDISK CLINDAMYCIN, 2MCG

Susceptibility Test Discs, Antimicrobial

HARDY DIAGNOSTICS

The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Clindamycin, 2mcg.

Pre-market Notification Details

Device IDK002662
510k NumberK002662
Device Name:HARDYDISK CLINDAMYCIN, 2MCG
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 Received2000-08-25
Decision Date2000-11-02

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816576020638 K002662 000
00816576020621 K002662 000

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