FDA 510(k) Applications Submitted by Hardy Diagnostics

FDA 510(k) Number Submission Date Device Name Applicant
K160512 02/24/2016 HardyCHROM ESBL HARDY DIAGNOSTICS
K062245 08/02/2006 HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936 HARDY DIAGNOSTICS
K172621 08/31/2017 HardyDisk Meropenem/Vaborbactam 20/10╡g (MEV30) Hardy Diagnostics
K230827 03/27/2023 HardyDisk AST Rezafungin 5╡g (RZF5) Hardy Diagnostics
K231568 05/31/2023 HardyDisk AST Sulbactam/Durlobactam 10/10╡g (SUD20) Hardy Diagnostics
K181700 06/27/2018 HardyDisk AST Plazomicin 30ug (PLZ30) Hardy Diagnostics
K191931 07/19/2019 HardyDisk AST Imipenem/relebactam 10/25╡g (IMR10/25) Hardy Diagnostics
K192326 08/27/2019 HardyDisk AST Lefamulin 20╡g (LMU20) Hardy Diagnostics
K182357 08/30/2018 HardyDisk AST Eravacycline 20╡g (ERV20) Hardy Diagnostics
K183298 11/27/2018 HardyDisk AST Omadacycline 30╡g (OMC30) Hardy Diagnostics
K170586 02/28/2017 Strep B Carrot Broth One-Step Hardy Diagnostics
K000128 01/18/2000 HARDYDISK, CEFAZOLIN, 30MCG HARDY DIAGNOSTICS
K000130 01/18/2000 HARDYDISK, NALIDIXIC ACID, 30MCG HARDY DIAGNOSTICS
K000203 01/21/2000 HARDYDISK, KANAMYCIN, 30MCG HARDY DIAGNOSTICS
K000201 01/21/2000 HARDYDISK, STREPTOMYCIN 10MCG HARDY DIAGNOSTICS
K001728 06/07/2000 HARDY DISK CLARITHROMYCIN, 15MCG HARDY DIAGNOSTICS
K993812 11/10/1999 CVM TRANSPORT, MODEL R96,VIRAL TRANSPORT, MODEL R99, CVM TRANSPORT KIT, MODEL R96 K, VIRAL TRANSPORT KIT, MODEL R99 K HARDY DIAGNOSTICS
K955451 11/29/1995 CVM TRANSPORT HARDY DIAGNOSTICS
K000181 01/20/2000 HARDYDISK, CARBENICILLIN, 100MCG HARDY DIAGNOSTICS
K000022 01/04/2000 HARDYDISK CEFAMANDOLE, 30MCG HARDY DIAGNOSTICS
K960075 01/11/1996 CHROMAGAR CANDIDA HARDY DIAGNOSTICS
K000182 01/20/2000 HARDYDISK TOBRAMYCIN, 10MCG HARDY DIAGNOSTICS
K000175 01/20/2000 HARDYDISK TICARILLIN 75MCG HARDY DIAGNOSTICS
K000183 01/20/2000 HARDYDISK, PIPERACILLIN, 100MCG HARDY DIAGNOSTICS
K000272 01/28/2000 HARDYDISK, NITROFURANTOIN HARDY DIAGNOSTICS
K000271 01/28/2000 HARDYDISK, SULFA/TRIMETH HARDY DIAGNOSTICS
K000268 01/28/2000 HARDYDISK, AMPICILLIN, 10MCG HARDY DIAGNOSTICS
K000261 01/28/2000 HARDYDISK, PIPERACILLIN/TAZOBACTAM, 110MCG HARDY DIAGNOSTICS
K000259 01/28/2000 HARDYDISK, CEFTAZIDIME, 30MCG HARDY DIAGNOSTICS
K000258 01/28/2000 HARDYDISK, CIPROFLOXACIN, 5MCG HARDY DIAGNOSTICS
K000305 02/01/2000 HARDYDISK, CEFOXITIN, 30MCG HARDY DIAGNOSTICS
K000302 02/01/2000 HARDY DISK, PENICILLIN, 10 UNITS HARDY DIAGNOSTICS
K000304 02/01/2000 HARDYDISK, TETRACYCLINE 30MCG HARDY DIAGNOSTICS
K000440 02/10/2000 HARDYDISK CEFTRIAXONE 30MCG HARDY DIAGNOSTICS
K000509 02/15/2000 HARDYDISK, VANCOMYCIN 30MCG HARDY DIAGNOSTICS
K000525 02/16/2000 HARDYDISK OFLOXACIN 5MCG HARDY DIAGNOSTICS
K000524 02/16/2000 HARDYDISK, CEFOTAXIME 30MCG HARDY DIAGNOSTICS
K000526 02/16/2000 HARDYDISK, CEPHALOTHIN 30MCG HARDY DIAGNOSTICS
K011086 04/10/2001 HARDYDISK BACITRACIN, 10MCG, MODEL Z927 HARDY DIAGNOSTICS
K001489 05/12/2000 HARDYDISK CEFOPERAZONE, 75 MCG HARDY DIAGNOSTICS
K001490 05/12/2000 HARDYDISK CEFONICID, 30 MCG HARDY DIAGNOSTICS
K001487 05/12/2000 HARDYDISK CINOXACIN, 100 MCG HARDY DIAGNOSTICS
K002368 08/03/2000 HARDYDISK STREPTOMYCIN, 300MCG HARDY DIAGNOSTICS
K002369 08/03/2000 HARDYDISK GENTAMICIN, 120MCG HARDY DIAGNOSTICS
K002367 08/03/2000 HARDY DISK CEFTIZOXIME, 30MCG HARDY DIAGNOSTICS
K002661 08/25/2000 HARDYDISK CEFOTETAN, 30MCG HARDY DIAGNOSTICS
K002660 08/25/2000 HARDYDISK LOMEFLOXACIN, 10MCG HARDY DIAGNOSTICS
K002656 08/25/2000 HARDYDISK CEFUROXIME, 30MCG HARDY DIAGNOSTICS
K002663 08/25/2000 HARDYDISK NETILMICIN, 30MCG HARDY DIAGNOSTICS
K002664 08/25/2000 HARDYDISK LEVOFLOXACIN, 5MCG HARDY DIAGNOSTICS
K002662 08/25/2000 HARDYDISK CLINDAMYCIN, 2MCG HARDY DIAGNOSTICS
K964560 11/13/1996 BHI W/VANCOMYCIN AGAR HARDY DIAGNOSTICS
K003536 11/16/2000 HARDYDISK NAFCILLIN, 1 MCG HARDY DIAGNOSTICS
K003537 11/16/2000 HARDYDISK RIFAMPIN, 5MCG HARDY DIAGNOSTICS
K003554 11/17/2000 HARDYDISK TRIMETHOPRIM 5MCG HARDY DIAGNOSTICS
K003556 11/17/2000 HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG HARDY DIAGNOSTICS
K993994 11/24/1999 HARDYDISK AZITHROMYCIN 15MCG HARDY DIAGNOSTICS
K994046 11/29/1999 HARDYDISK CEFACLOR 30MCG HARDY DIAGNOSTICS
K994051 11/30/1999 HARDYDISK DOXYCYCLINE, 30MCG HARDY DIAGNOSTICS
K003686 11/30/2000 HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG HARDY DIAGNOSTICS
K003690 11/30/2000 HARDYDISK SULFISOXAZOLE HARDY DIAGNOSTICS
K994063 12/01/1999 HARDYDISK AZTREONAM, 30MCG HARDY DIAGNOSTICS
K994067 12/01/1999 HARDY DISK AMPICILLIN/SULBACTAM HARDY DIAGNOSTICS
K994089 12/03/1999 HARDYDISK CHLORAMPHENICOL, 30MCG HARDY DIAGNOSTICS
K994091 12/03/1999 HARDYDISK GENTAMICIN, 10MCG HARDY DIAGNOSTICS
K994129 12/07/1999 HARDYDISK CEFIXIME, 5MCG HARDY DIAGNOSTICS
K994132 12/07/1999 HARDYDISK IMIPENEM, 10MCG HARDY DIAGNOSTICS
K994134 12/07/1999 HARDYDISK OXACILLIN, 1MCG HARDY DIAGNOSTICS
K994135 12/07/1999 HARDYDISK ERYTHROMYCIN, 15MCG HARDY DIAGNOSTICS
K994150 12/08/1999 HARDYDISK NORFLOXACIN, 10MCG HARDY DIAGNOSTICS
K994212 12/14/1999 HARDYDISK MEZLOCILLIN 75MCG HARDY DIAGNOSTICS
K960996 03/12/1996 M. CAT BUTYRATE DISK HARDY DIAGNOSTICS
K961191 03/26/1996 COLISCREEN HARDY DIAGNOSTICS
K011384 05/07/2001 HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883 HARDY DIAGNOSTICS
K011385 05/07/2001 HARDKYDISK NEOMYCIN, 30 MCG HARDY DIAGNOSTICS
K003532 11/16/2000 HARDY DISK, CEFPODOXINE, 10MCG HARDY DIAGNOSTICS
K993993 11/24/1999 HARDYDISK AMIKACIN 30MCG HARDY DIAGNOSTICS
K102922 10/01/2010 HARDYCHROM MRSA HARDY DIAGNOSTICS
K170127 01/13/2017 HardyDisk Ceftolozane/Tazobactam, (30/10 ug)-C/T40 Hardy Diagnostics
K170481 02/16/2017 Strep B Carrot Broth Kit Hardy Diagnostics
K190553 03/05/2019 HardyCHROM CRE Hardy Diagnostics
K171975 06/30/2017 HardyDisk AST Delafloxacin 5 ╡g (DLX5) Hardy Diagnostics
K193504 12/18/2019 HardyDisk AST Cefiderocol 30ug (FDC30) Hardy Diagnostics
K173903 12/22/2017 Granada Medium Hardy Diagnostics
K152838 09/29/2015 HardyDisk AST Ceftazidime/Avibactam, (30/20ug)-CZA50 HARDY DIAGNOSTICS
K152846 09/29/2015 HardyDisk AST Ceftolozane/Tazobactam, (30/10ug)- C/T40 HARDY DIAGNOSTICS
K103538 12/02/2010 HARDYDISK AST CEFTAROLINE, 30 UG MODEL Z939 HARDY DIAGNOSTICS
K093807 12/11/2009 HARDYDISK AST TELAVANCIN,30UG HARDY DIAGNOSTICS
K080019 01/03/2008 HARDYDISK AST DORIPENEM 10 UG HARDY DIAGNOSTICS


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