Radiometer America, Inc. - FDA 510(k) Cleared Devices
50
Total
50
Cleared
0
Denied
34 devices
Cleared
Jan 28, 2016
VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7...
Chemistry
35d
Cleared
Jan 10, 2000
ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
Chemistry
138d
Cleared
Nov 24, 1999
ABL 735 ANALYZER
Chemistry
215d
Cleared
Jan 06, 1999
NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
Chemistry
139d
Cleared
Feb 09, 1998
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
Chemistry
26d
Cleared
Jan 28, 1998
QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
Chemistry
13d
Cleared
Jan 16, 1998
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
Chemistry
24d
Cleared
Oct 06, 1997
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
Chemistry
28d
Cleared
Oct 29, 1996
PICO MODELS 30, 50, 70
Chemistry
147d
Cleared
Oct 24, 1996
EML105 ELECTROLYTE METABOLITE ANALYZER
Chemistry
129d
Cleared
Jun 14, 1996
QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)
Chemistry
67d
Cleared
Jun 14, 1996
MULTICHECK
Chemistry
67d