CHL · Class II · 21 CFR 862.1120

FDA Product Code CHL: Electrode Measurement, Blood-gases (pco2, Po2) And Blood Ph

Leading manufacturers include Nova Biomedical Corp., Radiometer America, Inc. and Fisher Scientific Co., LLC.

188
Total
188
Cleared
103d
Avg days
1976
Since
188 devices
25–48 of 188
Cleared Mar 25, 2014
NOVA STAT PROFILE PRIME CCS ANALYZER SYSTEM
K131703
Nova Biomedical Corporation
Chemistry · 287d
Cleared Jan 13, 2014
GEM PREMIER 4000
K133407
Instrumentation Laboratory CO
Chemistry · 68d
Cleared Sep 17, 2013
ABL90 FLEX ANALYZER
K131988
Radiometer Medical Aps
Chemistry · 81d
Cleared Aug 22, 2013
OPTI CCA-TS2
K131126
Opti Medical Systems, Inc.
Chemistry · 122d
Cleared Jul 31, 2013
ABL90 FLEX
K130144
Radiometer Medical Aps
Chemistry · 190d
Cleared May 07, 2013
ABL90 FLEX
K123748
Radiometer Medical Aps
Chemistry · 152d
Cleared Apr 19, 2013
MEASUREMENT OF PH IN PLEURAL FLUID ON BLOOD GAS SYSTEM
K122539
Siemens Healthcare Diagnostics
Chemistry · 241d
Cleared Nov 16, 2012
ABL90 FLEX
K122729
Radiometer Medical Aps
Chemistry · 71d
Cleared Oct 26, 2012
ABL90 FLEX
K122642
Radiometer Medical Aps
Chemistry · 58d
Cleared May 14, 2012
COBAS B 123 POC SYSTEM, COBAS B 123 AUTOQC PACK TRI-LEVEL, COBAS B 123 AUTOCVC PACK, ROCHE COMBITROL PLUS B
K111188
Roche Diagnostics
Chemistry · 383d
Cleared Mar 19, 2012
ABL90 FLEX
K120197
Radiometer Medical Aps
Chemistry · 56d
Cleared Aug 29, 2011
NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
K110648
Nova Biomedical Corporation
Chemistry · 178d
Cleared Jul 19, 2011
ABL90
K111897
Radiometer Medical Aps
Chemistry · 14d
Cleared Mar 24, 2011
ABL835 FLEX ANALYZER WITH PLEURAL PH
K110416
Radiometer Medical Aps
Chemistry · 38d
Cleared Dec 10, 2010
ABL837 FLEX ANALYZER
K100777
Radiometer Medical Aps
Chemistry · 267d
Cleared Jun 25, 2007
EASYSTAT PH, PCO2, PO2, HTC, NA, K, CL ANALYZER
K063376
Medica Corp.
Chemistry · 229d
Cleared Sep 15, 2006
GEM PREMIER 4000 WITH IQM, MODEL 4000
K061974
Instrumentation Laboratory CO
Chemistry · 65d
Cleared Nov 01, 2005
ABL80 FLEX ANALYZER
K051804
Sendx Medical, Inc.
Chemistry · 119d
Cleared May 10, 2005
ABL800 FLEX WITH FLEXQ MODULE, MODEL ABL8XX
K043218
Radiometer Medical Aps
Chemistry · 169d
Cleared Apr 22, 2005
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
K050423
Roche Diagnostics
Chemistry · 63d
Cleared Oct 08, 2004
ABL800 FLEX
K041874
Radiometer Medical Aps
Chemistry · 88d
Cleared Dec 17, 2003
BAYER RAPIDLAB 1200 SYSTEM
K031560
Bayer Healthcare, LLC
Chemistry · 212d
Cleared Dec 20, 2002
STAT PROFILE PHOX PLUS L ANALYZER
K023567
Nova Biomedical Corp.
Chemistry · 58d
Cleared Nov 22, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K022746
Nova Biomedical Corp.
Chemistry · 95d