Bionostics, Inc. - FDA 510(k) Cleared Devices
49
Total
49
Cleared
0
Denied
49 devices
Cleared
Aug 27, 2001
MULTI-METER GLUCOSE CALIBRATION VERIFICATION MATERIAL, MODEL RNA GL3
Chemistry
27d
Cleared
Sep 18, 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH MEDISENSE BLOOD...
Chemistry
33d
Cleared
Feb 28, 2000
BIONOSTICS GLUCOSE QUALITY CONTROL SOLUTION FOR USE WITH THE FASTTAKE COMPACT...
Chemistry
27d
Cleared
Feb 12, 1998
OXYHEMOGLOBIN CONTROL FOR CO-OXIMETRY
Chemistry
23d
Cleared
Aug 28, 1997
TRADEMARK BLOOD GAS/ELECTROLYTE/GLUCOSE, LACTATE, BUN AND CREATININE CONTROL
Chemistry
24d
Cleared
Mar 01, 1996
RNA MEDICAL HEMAT CONTROL
Hematology
81d
Cleared
Feb 22, 1995
RNA MEDICAL'S EQUIL PLUS WITH GLUCOSE CONTROL
Chemistry
21d
Cleared
Sep 14, 1994
BLOOD GADS, ELECTROLYTE, GLUCOSE, LATATE AND BUN QUALITY CONTROL PRODUCT
Chemistry
43d
Cleared
Jun 30, 1992
RNA MEDICAL'S EQUIL 55
Chemistry
42d
Cleared
Jun 26, 1992
RNA MEDICAL TONOMETER
Chemistry
37d
Cleared
Sep 27, 1991
CHALITY CONTROL MATERIAL (ASSAYED & UNASSAYED)
Chemistry
73d
Cleared
May 22, 1991
CONTROL FOR PH,BLOOD GASES,ELETROLYTES,GLUCOSE
Chemistry
34d
Cleared
Nov 28, 1990
SECONDARY CALIBRATORS
Chemistry
43d
Cleared
Oct 12, 1990
SECONDARY CALIBRATORS
Chemistry
22d
Cleared
May 27, 1988
MULTI-FUNCTION BLOOD GAS CONTROL
Chemistry
115d
Cleared
Mar 24, 1988
PROTEIN BASE ISE CONTROL
Chemistry
31d
Cleared
Dec 14, 1987
MULTI-FUNCTION BLOOD GAS CONTROL
Chemistry
47d
Cleared
May 20, 1985
MULTI FUNCTION BLOOD GAS CONTROL
Chemistry
19d
Cleared
Jun 14, 1984
BLOOD GAS CONTROL, LEVEL I(ACIDOSIS
Chemistry
45d
Cleared
Apr 17, 1984
POTASSIUM CHLORIDE TABLETS
Chemistry
53d
Cleared
Mar 23, 1984
PH ELECTRODE CALIBRATING BUFFERS-BLOOD
Chemistry
59d
Cleared
Mar 23, 1984
FLUSH SOLUTION CONCENTRATE-BLOOD GAS
Chemistry
59d
Cleared
Nov 28, 1983
AQUEOUS BLOOD GAS CONTROL
Chemistry
74d
Cleared
Jul 18, 1983
CALIBRATOR 282
Hematology
35d