Radiometer America, Inc. - FDA 510(k) Cleared Devices
50
Total
50
Cleared
0
Denied
34 devices
Cleared
Dec 13, 1990
ABL510 BLOOD GAS SYSTEM
Chemistry
72d
Cleared
Nov 02, 1990
QUALICHECK 3
Chemistry
16d
Cleared
Jan 23, 1990
QS90 SMOOTH E ARTERIAL BLOOD SAMPLER
Chemistry
70d
Cleared
Oct 06, 1989
ABL500 BLOOD GAS SYSTEM
Chemistry
56d
Cleared
Aug 03, 1989
QUALICHECK 2
Chemistry
52d
Cleared
Mar 05, 1986
ABL330 ACID BASE LABORATORY
Chemistry
58d
Cleared
Dec 30, 1985
OSM3 HEMOXIMETER
Chemistry
94d
Cleared
Jan 18, 1984
ACID BASE LABORATORY ABL4
Chemistry
92d
Cleared
Apr 08, 1983
KNAI SODIUM POTASSIUM ANALYZER
Chemistry
25d