HARDYDISK AST TELAVANCIN,30UG

Susceptibility Test Discs, Antimicrobial

HARDY DIAGNOSTICS

The following data is part of a premarket notification filed by Hardy Diagnostics with the FDA for Hardydisk Ast Telavancin,30ug.

Pre-market Notification Details

Device IDK093807
510k NumberK093807
Device Name:HARDYDISK AST TELAVANCIN,30UG
ClassificationSusceptibility Test Discs, Antimicrobial
Applicant HARDY DIAGNOSTICS 1430 WEST MCCOY LN. Santa Maria,  CA  93455
ContactWendy Philips
CorrespondentWendy Philips
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 Received2009-12-11
Decision Date2010-01-08

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00816576021895 K093807 000
00816576021888 K093807 000

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