HARDYDISK LEVOFLOXACIN, 5MCG

Susceptibility Test Discs, Antimicrobial

HARDY DIAGNOSTICS

The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Levofloxacin, 5mcg.

Pre-market Notification Details

Device IDK002664
510k NumberK002664
Device Name:HARDYDISK LEVOFLOXACIN, 5MCG
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 Date2000-10-26

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816576020751 K002664 000
00816576020744 K002664 000

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.