Nova Biomedical Corp. - FDA 510(k) Cleared Devices
89
Total
89
Cleared
0
Denied
80 devices
Cleared
Jan 15, 1992
NOVA 4 NA/K/C1/TCO2/LI ANALYZER
Chemistry
61d
Cleared
Sep 11, 1991
NOVA 13 ANALYZER
Chemistry
92d
Cleared
Jul 17, 1991
NOVA 12 ANALYZER
Chemistry
36d
Cleared
Jul 01, 1991
NOVA 1 SODIUM/POTASSIUM/HEMATOCRIT ANALYZER
Chemistry
20d
Cleared
Jun 17, 1991
MODULE: NOVA NUCLEUS TMG MODULE FLUID PACK
Chemistry
24d
Cleared
Mar 05, 1991
STAT PROFILE 8 ANALYZER,CALIBRATORS AND MATERIALS
Chemistry
104d
Cleared
Mar 27, 1990
CALIBRATORS, CONTROL MATERIALS, ELECTRODES & TUBE
Chemistry
90d
Cleared
Sep 07, 1989
NOVA NUCLEUS CLINICAL CHEMISTRY SYSTEM
Chemistry
80d
Cleared
Dec 02, 1988
NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER
Chemistry
63d
Cleared
Jul 01, 1988
NOVA STAT PROFILE 6 ANALYZER + QUALITY CONTROL MAT
Chemistry
128d
Cleared
May 16, 1988
NOVA 12 NA/K/C1/TOTAL CARBON DIOXIDE/GLUCOSE/UREA
Chemistry
54d
Cleared
Feb 11, 1988
NOVA STAT PROFILE 5 ANALYZER + QUALITY CONTROL
Chemistry
79d
Cleared
Jun 24, 1987
NOVA 13 SODIUM/POTASSIUM/CHLORIDE/LITHIUM ANALYZER
Chemistry
16d
Cleared
Jun 03, 1987
ANALYZER: NOVA STAT PROFILE 3 ANALYZER
Chemistry
57d
Cleared
Feb 04, 1987
STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL
Chemistry
84d
Cleared
Sep 29, 1986
NOVA II SODIUM/POTASSIUM/LITHIUM ANALYZER
Chemistry
24d
Cleared
Dec 05, 1985
ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT.
Chemistry
17d
Cleared
Jun 22, 1984
NOVA STAT CONTROL LEVELS 1/2/3
Chemistry
74d
Cleared
Jun 22, 1984
CHANGES IN THE CHEMICAL COMP. OF 5
Chemistry
102d
Cleared
Dec 08, 1983
NOVA 9 SODIUM/POTASSIUM/TOTAL CALCIUM
Chemistry
84d
Cleared
Nov 25, 1983
NOVA 10 SODIUM/POTASSIUM/TOTAL CALCIU
Chemistry
71d
Cleared
Apr 05, 1983
NOVA 7 TOTAL CALCIUM/IONIZED CALCIUM
Chemistry
71d
Cleared
Mar 24, 1983
NOVA 8 IONIZED CALCIUM/PH ANALYZER
Chemistry
36d
Cleared
Feb 02, 1983
SODIUM/POTASSIUM/IONIZED CALCIUM ANALYZ
Chemistry
79d
Cleared
May 27, 1981
NOVA 5
Chemistry
16d
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