Medical Device Manufacturer · US , Santa Maria , CA

Hardy Diagnostics - FDA 510(k) Cleared Devices

108 submissions · 108 cleared · Since 1993
108
Total
108
Cleared
0
Denied
108 devices
26-50 of 108
Cleared Jan 08, 2010
HARDYDISK AST TELAVANCIN,30UG
K093807 · JTN
Microbiology · 28d
Cleared Jan 29, 2008
HARDYDISK AST DORIPENEM 10 UG
K080019 · JTN
Microbiology · 26d
Cleared Aug 23, 2006
HARDY DISK AST TIGECYCLINE 15 UG, MODELZ936
K062245 · JTN
Microbiology · 21d
Cleared Jun 13, 2001
HARDYDISK NOVOBIOCIN, 30MCG, MODEL Z883
K011384 · JTN
Microbiology · 37d
Cleared May 18, 2001
HARDKYDISK NEOMYCIN, 30 MCG
K011385 · JTN
Microbiology · 11d
Cleared Apr 26, 2001
HARDYDISK BACITRACIN, 10MCG, MODEL Z927
K011086 · JTN
Microbiology · 16d
Cleared Jan 25, 2001
HARDYDISK SULFISOXAZOLE
K003690 · JTN
Microbiology · 56d
Cleared Jan 19, 2001
HARDYDISK TRIMETHOPRIM 5MCG
K003554 · JTN
Microbiology · 63d
Cleared Jan 17, 2001
HARDYDISK AMOXICILLIN/CLAVULANIC ACID, 20/10MCG
K003556 · JTN
Microbiology · 61d
Cleared Jan 12, 2001
HARDYDISK NAFCILLIN, 1 MCG
K003536 · JTN
Microbiology · 57d
Cleared Jan 12, 2001
HARDYDISK RIFAMPIN, 5MCG
K003537 · JTN
Microbiology · 57d
Cleared Jan 12, 2001
HARDYDISK TICARCILLIN/CLAVULANIC ACID, 85MCG
K003686 · JTN
Microbiology · 43d
Cleared Dec 13, 2000
HARDY DISK, CEFPODOXINE, 10MCG
K003532 · JTN
Microbiology · 27d
Cleared Nov 02, 2000
HARDYDISK CLINDAMYCIN, 2MCG
K002662 · JTN
Microbiology · 69d
Cleared Oct 26, 2000
HARDY DISK CEFTIZOXIME, 30MCG
K002367 · JTN
Microbiology · 84d
Cleared Oct 26, 2000
HARDYDISK GENTAMICIN, 120MCG
K002369 · JTN
Microbiology · 84d
Cleared Oct 26, 2000
HARDYDISK LOMEFLOXACIN, 10MCG
K002660 · JTN
Microbiology · 62d
Cleared Oct 26, 2000
HARDYDISK CEFOTETAN, 30MCG
K002661 · JTN
Microbiology · 62d
Cleared Oct 26, 2000
HARDYDISK LEVOFLOXACIN, 5MCG
K002664 · JTN
Microbiology · 62d
Cleared Oct 25, 2000
HARDYDISK STREPTOMYCIN, 300MCG
K002368 · JTN
Microbiology · 83d
Cleared Oct 25, 2000
HARDYDISK CEFUROXIME, 30MCG
K002656 · JTN
Microbiology · 61d
Cleared Oct 19, 2000
HARDYDISK NETILMICIN, 30MCG
K002663 · JTN
Microbiology · 55d
Cleared Jul 27, 2000
HARDY DISK CLARITHROMYCIN, 15MCG
K001728 · JTN
Microbiology · 50d
Cleared Jun 07, 2000
HARDYDISK CINOXACIN, 100 MCG
K001487 · JTN
Microbiology · 26d
Cleared Jun 01, 2000
HARDYDISK CEFOPERAZONE, 75 MCG
K001489 · JTN
Microbiology · 20d

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