Hardy Diagnostics

FDA Filings

This page includes the latest FDA filings for Hardy Diagnostics. Currently, you will find the latest 25 filings for Premarket Notifications, Premarket Applications, De Novo Applications, and GUDID registrations.

Latest Premarket Notifications

ManufacturerDevice NameDate
Hardy Diagnostics
HardyDisk AST Cefiderocol 30ug (FDC30)2020-01-23
Hardy Diagnostics
HardyDisk AST Lefamulin 20µg (LMU20)2019-09-19
Hardy Diagnostics
HardyDisk AST Imipenem/relebactam 10/25µg (IMR10/25)2019-07-31
Hardy Diagnostics
HardyCHROM CRE2019-04-29
Hardy Diagnostics
HardyDisk AST Omadacycline 30µg (OMC30)2019-01-18
Hardy Diagnostics
HardyDisk AST Eravacycline 20µg (ERV20)2018-09-26
Hardy Diagnostics
HardyDisk AST Plazomicin 30ug (PLZ30)2018-07-10
Hardy Diagnostics
Granada Medium2018-03-22
Hardy Diagnostics
HardyDisk Meropenem/Vaborbactam 20/10µg (MEV30)2017-10-03
Hardy Diagnostics
HardyDisk AST Delafloxacin 5 µg (DLX5)2017-08-01
Hardy Diagnostics
Strep B Carrot Broth One-step2017-05-22
Hardy Diagnostics
Strep B Carrot Broth Kit2017-05-16
Hardy Diagnostics
Hardydisk Ceftolozane/tazobactam, (30/10 Ug)-c/t402017-03-14
HARDY DIAGNOSTICS
HardyCHROM ESBL2016-11-15
HARDY DIAGNOSTICS
HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA502015-11-24
HARDY DIAGNOSTICS
HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T402015-11-24
HARDY DIAGNOSTICS
HARDYCHROM MRSA2011-05-04
HARDY DIAGNOSTICS
HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z9392010-12-17
HARDY DIAGNOSTICS
HARDYDISK AST TELAVANCIN,30UG2010-01-08
HARDY DIAGNOSTICS
HARDYDISK AST DORIPENEM 10 UG2008-01-29
HARDY DIAGNOSTICS
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ9362006-08-23
HARDY DIAGNOSTICS
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z8832001-06-13
HARDY DIAGNOSTICS
HARDYDISK BACITRACIN, 10MCG, MODEL Z9272001-04-26
HARDY DIAGNOSTICS
HARDYDISK SULFISOXAZOLE2001-01-25
HARDY DIAGNOSTICS
HARDYDISK TRIMETHOPRIM 5MCG2001-01-19
HARDY DIAGNOSTICS
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG2001-01-12
HARDY DIAGNOSTICS
HARDY DISK, CEFPODOXINE, 10MCG2000-12-13
HARDY DIAGNOSTICS
Hardydisk Clindamycin, 2mcg2000-11-02
HARDY DIAGNOSTICS
Hardy Disk Ceftizoxime, 30mcg2000-10-26
HARDY DIAGNOSTICS
HARDYDISK CEFOTETAN, 30MCG2000-10-26

Latest Premarket Applications

PMAManufacturerDevice NameDate

Latest De Novo Filings

De NovoManufacturerDevice NameDate

GUDID Registrations

Device GUDID
Device Name
ManufacturerDate
HardyCHROM™
HARDY DIAGNOSTICS2019-10-29
HardyDisk™
HARDY DIAGNOSTICS2019-10-29
HardyDisk™
HARDY DIAGNOSTICS2019-10-29
HardyDisk™
HARDY DIAGNOSTICS2019-10-25
HardyDisk™
HARDY DIAGNOSTICS2019-10-25
NA
HARDY DIAGNOSTICS2019-10-21
HardyDisk™
HARDY DIAGNOSTICS2019-01-18
HardyDisk™
HARDY DIAGNOSTICS2019-01-18
HardyDisk™
HARDY DIAGNOSTICS2019-01-07
HardyDisk™
HARDY DIAGNOSTICS2019-01-07
HardyDisk™
HARDY DIAGNOSTICS2019-01-07
HardyDisk™
HARDY DIAGNOSTICS2019-01-07
HardyDisk™
HARDY DIAGNOSTICS2019-01-07
HardyDisk™
HARDY DIAGNOSTICS2019-01-07
NA
HARDY DIAGNOSTICS2018-08-31
NA
HARDY DIAGNOSTICS2018-08-31
NA
HARDY DIAGNOSTICS2018-08-31
NA
HARDY DIAGNOSTICS2018-08-31
NA
HARDY DIAGNOSTICS2018-08-31
NA
HARDY DIAGNOSTICS2018-08-31
NA
HARDY DIAGNOSTICS2018-08-31
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06
HardyDisk™
HARDY DIAGNOSTICS2018-07-06

Related Finance Registrations
D.U.N.S. 039981550 [Hardy Diagnostics]

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