Medical Device Manufacturer · US , Mchenry , IL

Nova Biomedical Corp. - FDA 510(k) Cleared Devices

89 submissions · 89 cleared · Since 1977
89
Total
89
Cleared
0
Denied
89 devices
26-50 of 89
Cleared May 12, 1998
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
K981426 · GKF
Hematology · 26d
Cleared May 12, 1998
STAT PROFILE M ANALYZER
K981427 · GKF
Hematology · 26d
Cleared Apr 15, 1998
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
K980991 · CHL
Chemistry · 29d
Cleared May 09, 1997
STAT PROFILE ULTRA M ANALYZER
K970710 · CHL
Chemistry · 72d
Cleared Aug 23, 1996
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT
K962982 · JJY
Chemistry · 22d
Cleared Aug 23, 1996
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
K963005 · JFL
Chemistry · 21d
Cleared Aug 15, 1996
NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3
K962997 · JJY
Chemistry · 13d
Cleared Jun 28, 1996
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
K961938 · GJS
Hematology · 39d
Cleared Apr 25, 1996
NOVA CO-OXIMETER ANALYZER
K955013 · GLY
Hematology · 176d
Cleared Mar 11, 1996
STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
K960120 · JFP
Chemistry · 60d
Cleared Feb 02, 1996
NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4
K955252 · JJY
Chemistry · 79d
Cleared Feb 02, 1996
NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION
K955260 · JJY
Chemistry · 79d
Cleared Feb 02, 1996
NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2
K955264 · JJY
Chemistry · 79d
Cleared Nov 30, 1995
STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)
K954711 · CHL
Chemistry · 63d
Cleared Jul 06, 1995
STAT PROFILE ULTRA BLOOD GAS CONTROLS
K952477 · JJS
Chemistry · 37d
Cleared Mar 09, 1995
STAT PROFILE PLUS 9 ANALYZER
K936066 · KHP
Chemistry · 443d
Cleared Mar 09, 1995
STAT PROFILE PLUS 10 ANALYZER
K936203 · CHL
Chemistry · 443d
Cleared Feb 08, 1995
NOVA 16 ANALYZER
K945584 · JJC
Chemistry · 86d
Cleared Dec 29, 1994
STAT PROFILE ULTRA 11 ANALYZER
K943643 · CHL
Chemistry · 155d
Cleared Jun 15, 1993
ANALYZER: STAT PROFILE PLUS 10 ANALYZER
K931373 · JJY
Chemistry · 89d
Cleared Feb 23, 1993
STAT PROFILE 9 ANALYZER
K924497 · CHL
Chemistry · 172d
Cleared Jan 28, 1993
NOVA 8 CRT ANALYZER
K924547 · JGS
Chemistry · 141d
Cleared Nov 06, 1992
NOVA 12 ANALYZER, MODIFICATION
K924743 · CGA
Chemistry · 53d
Cleared Nov 06, 1992
NOVA 13 ANALYZER, MODIFICATION
K924864 · CGZ
Chemistry · 56d
Cleared Oct 13, 1992
NOVA NA/K/CL/LI MODULE
K922943 · CEM
Chemistry · 117d

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