Nova Biomedical Corp. - FDA 510(k) Cleared Devices
89
Total
89
Cleared
0
Denied
89 devices
Cleared
May 12, 1998
STAT PROFILE ULTRA F,G,H,I,J,K, AND L ANALYZERS
Hematology
26d
Cleared
May 12, 1998
STAT PROFILE M ANALYZER
Hematology
26d
Cleared
Apr 15, 1998
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
Chemistry
29d
Cleared
May 09, 1997
STAT PROFILE ULTRA M ANALYZER
Chemistry
72d
Cleared
Aug 23, 1996
NOVA CHEMISTRY CONTROLS, LEVEL 1,2,AND 3 W/O CREAT
Chemistry
22d
Cleared
Aug 23, 1996
NOVA 16 ANALYZER (MODIFICATION POINT OF CARE USAGE)
Chemistry
21d
Cleared
Aug 15, 1996
NOVA CHEMISTRY CONTROLS WITH CREATININE, LEVELS (1, 2) AND 3
Chemistry
13d
Cleared
Jun 28, 1996
STAT PROFILE ULTRA L ANALYZER QUALITY CONTROL MATERIALS
Hematology
39d
Cleared
Apr 25, 1996
NOVA CO-OXIMETER ANALYZER
Hematology
176d
Cleared
Mar 11, 1996
STAT PROFILE ULTRA F,G,H,I,J, AND K ANALYZERS
Chemistry
60d
Cleared
Feb 02, 1996
NOVA CHEMISTRY LINEARITY SET F, LEVELS 1, 2, 3, AND 4
Chemistry
79d
Cleared
Feb 02, 1996
NOVA CHEMISTRY PERFORMANCE CHECK SOLUTION
Chemistry
79d
Cleared
Feb 02, 1996
NOVA CHEMISTRY CONTROLS, LEVELS 1 AND 2
Chemistry
79d
Cleared
Nov 30, 1995
STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)
Chemistry
63d
Cleared
Jul 06, 1995
STAT PROFILE ULTRA BLOOD GAS CONTROLS
Chemistry
37d
Cleared
Mar 09, 1995
STAT PROFILE PLUS 9 ANALYZER
Chemistry
443d
Cleared
Mar 09, 1995
STAT PROFILE PLUS 10 ANALYZER
Chemistry
443d
Cleared
Feb 08, 1995
NOVA 16 ANALYZER
Chemistry
86d
Cleared
Dec 29, 1994
STAT PROFILE ULTRA 11 ANALYZER
Chemistry
155d
Cleared
Jun 15, 1993
ANALYZER: STAT PROFILE PLUS 10 ANALYZER
Chemistry
89d
Cleared
Feb 23, 1993
STAT PROFILE 9 ANALYZER
Chemistry
172d
Cleared
Jan 28, 1993
NOVA 8 CRT ANALYZER
Chemistry
141d
Cleared
Nov 06, 1992
NOVA 12 ANALYZER, MODIFICATION
Chemistry
53d
Cleared
Nov 06, 1992
NOVA 13 ANALYZER, MODIFICATION
Chemistry
56d
Cleared
Oct 13, 1992
NOVA NA/K/CL/LI MODULE
Chemistry
117d
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