Radiometer America, Inc. - FDA 510(k) Cleared Devices
50
Total
50
Cleared
0
Denied
50 devices
Cleared
Mar 29, 1994
SENSI-CAL AMCO AEPA-1
Microbiology
131d
Cleared
Mar 09, 1993
SENSITITRE SUSCEPTIBILITY PLATES
Microbiology
258d
Cleared
Mar 09, 1993
CALIBRATION VERIFICATION KIT OR CVK
Chemistry
166d
Cleared
Sep 22, 1992
MICROBACT SOLID PLATE SYSTEMS
Microbiology
98d
Cleared
Aug 28, 1992
ABL50 BLOOD GAS SYSTEM
Chemistry
72d
Cleared
Feb 18, 1992
MICROBACT 12A SYSTEM, 12B SYSTEM, AND 24E SYSTEM
General Hospital
260d
Cleared
Jan 28, 1992
ABL505 BLOOD GAS & ELECTROLYTE SYSTEM
Chemistry
133d
Cleared
Jan 02, 1992
QUALICHECK 4
Chemistry
34d
Cleared
Jul 09, 1991
ABL520 BLOOD GAS SYSTEM
Hematology
132d
Cleared
Dec 13, 1990
ABL510 BLOOD GAS SYSTEM
Chemistry
72d
Cleared
Nov 02, 1990
QUALICHECK 3
Chemistry
16d
Cleared
Apr 16, 1990
E5280 COMBINED TRANSCUTANEOUS TCP02/TCPCO2 ELECT.
Anesthesiology
83d
Cleared
Jan 23, 1990
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
Chemistry
70d
Cleared
Oct 06, 1989
ABL500 BLOOD GAS SYSTEM
Chemistry
56d
Cleared
Sep 05, 1989
OXIMETER
Anesthesiology
119d
Cleared
Aug 31, 1989
SENSITITRE INDOLE REAGENT
Microbiology
35d
Cleared
Aug 03, 1989
QUALICHECK 2
Chemistry
52d
Cleared
Jun 09, 1989
SENSITITRE AUTO ID PLATE AP80
Microbiology
154d
Cleared
Jun 08, 1987
OXIMETER
Anesthesiology
63d
Cleared
Mar 05, 1986
ABL330 ACID BASE LABORATORY
Chemistry
58d
Cleared
Dec 30, 1985
OSM3 HEMOXIMETER
Chemistry
94d
Cleared
Dec 10, 1984
ABL300 ACID BASE LABORATORY
Hematology
34d
Cleared
Jan 18, 1984
ACID BASE LABORATORY ABL4
Chemistry
92d
Cleared
May 18, 1983
QUALISTICK ARTERIAL BLOOD SAMPLER
Anesthesiology
48d
Cleared
Apr 08, 1983
KNAI SODIUM POTASSIUM ANALYZER
Chemistry
25d