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., Fisher Scientific Co., LLC and Instrumentation Laboratory CO.

188
Total
188
Cleared
103d
Avg days
1976
Since
188 devices
25–48 of 188
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 Aug 29, 2011
NOVA STAT PROFILE PHOX ULTRA ANALYZER SYSTEM
K110648
Nova Biomedical Corporation
Chemistry · 178d
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 Apr 22, 2005
OMNI MODULAR, OMNI C AND OMNI S ANALYZER (PH ELECTRODE)
K050423
Roche Diagnostics
Chemistry · 63d
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
Cleared Jul 25, 2002
STAT PROFILE PHOX PLUS C ANALYZER
K021713
Nova Biomedical Corp.
Chemistry · 63d
Cleared Jul 16, 2002
EASYSTAT PH, PCO2, PO2, HCT, NA+, K+, CA++ ANALYZER
K021515
Medica Corp.
Chemistry · 67d
Cleared Jun 10, 2002
STAT PROFILE CRITICAL CARE XPRESS ANALYZER
K020297
Nova Biomedical Corp.
Chemistry · 133d
Cleared Feb 28, 2002
STAT PROFILE PHOX ANALYZER
K014295
Nova Biomedical Corp.
Chemistry · 62d
Cleared Jan 15, 2002
STAT PROFILE PHOX BASIC ANALYZER
K013729
Nova Biomedical Corp.
Chemistry · 67d
Cleared Aug 20, 2001
STAT PROFILE PHOX PLUS L ANALYZER
K012058
Nova Biomedical Corp.
Chemistry · 49d
Cleared Dec 19, 2000
BAYER RAPIDPOINT 400 SYSTEM
K002738
Bayer Corp.
Chemistry · 109d
Cleared Oct 19, 2000
MODIFICATION TO STAT PROFILE PHOX PLUS ANALYZER
K002613
Nova Biomedical Corp.
Chemistry · 58d
Cleared Jan 10, 2000
ABL700 SERIES ANALYZER WITH AUTOCHECK MODULE
K992859
Radiometer America, Inc.
Chemistry · 138d
Cleared Nov 24, 1999
ABL 735 ANALYZER
K991417
Radiometer America, Inc.
Chemistry · 215d
Cleared Nov 24, 1999
GEM PREMIER 3000
K992834
Instrumentation Laboratory CO
Chemistry · 93d
Cleared Jan 06, 1999
NPT7 SERIES PH/BLOOD GAS AND CO-OXIMETRY SYSTEM
K982928
Radiometer America, Inc.
Chemistry · 139d
Cleared Jul 22, 1998
MODIFICATION TO STAT PROFILE PHOX BLOOD GAS ANALYZER (K980991)
K982277
Nova Biomedical Corp.
Chemistry · 23d
Cleared Apr 15, 1998
NOVA STAT PROFILE PHOX BLOOD GAS ANALYZER
K980991
Nova Biomedical Corp.
Chemistry · 29d
Cleared Feb 09, 1998
ABL700 SERIES BLOOD GAS , CO-OXIMETRY, ELECTROLYTE & METABOLITE SYSTEM
K980130
Radiometer America, Inc.
Chemistry · 26d
Cleared Feb 05, 1998
EASYBLOOD GAS ANALYZER
K974526
Medica Corp.
Chemistry · 65d