Radiometer America, Inc. is one of 5575 FDA 510(k) medical device manufacturers from United States in the dataset, ranked by real submission volume.
Radiometer America, Inc. - FDA 510(k) Cleared Devices
Recent clearances: VK-3 Verification Kit, VK-4 Verification Kit, VK-R5 Verification Kit, VK-R7 Verification Kit, VK-Crea Verification Kit, ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE, ABL 735 ANALYZER
50
Total
50
Cleared
0
Denied
Radiometer America, Inc. has 50 FDA 510(k) cleared medical devices. Based in Mchenry, US.
Historical record: 50 cleared submissions from 1983 to 2016. Primary specialty: Chemistry.
Browse the FDA 510(k) cleared devices submitted by Radiometer America, Inc. Filter by specialty or product code using the sidebar.
510(k) submissions have been managed by Radiometer Medical Aps as regulatory consultant.
FDA 510(k) Regulatory Record - Radiometer America, Inc.
50 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
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