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., Instrumentation Laboratory CO and Radiometer America, Inc..

188
Total
188
Cleared
103d
Avg days
1976
Since
188 devices
73–96 of 188
Cleared May 09, 1997
STAT PROFILE ULTRA M ANALYZER
K970710
Nova Biomedical Corp.
Chemistry · 72d
Cleared Nov 29, 1996
AVL COMPACT 3 PH/BLOOD GAS ANALYZER
K963964
Avl Scientific Corp.
Chemistry · 58d
Cleared Nov 13, 1996
IL SYNTHESIS
K963800
Instrumentation Laboratory CO
Chemistry · 51d
Cleared Jun 28, 1996
GEM PREMIER PLUS MODEL 5500
K961335
Mallinckrodt Sensor Systems, Inc.
Chemistry · 81d
Cleared Jun 25, 1996
CIBA CORNING 400 SYSTEM
K961657
Ciba Corning Diagnostics Corp.
Chemistry · 56d
Cleared Jun 24, 1996
CIBA CORNING 348 SYSTEM
K962021
Ciba Corning Diagnostics Corp.
Chemistry · 32d
Cleared Apr 26, 1996
AVL OPTI 1 PH/BLOOD GAS ANALYZER
K961161
Avl Scientific Corp.
Chemistry · 35d
Cleared Feb 14, 1996
IL BGGE BLOOD GAS WITH GLUCOSE SYSTEM
K955793
Instrumentation Laboratory CO
Chemistry · 54d
Cleared Nov 30, 1995
STAT PROFILE ULTRA 11 ANALYZER (MODIFICATION)
K954711
Nova Biomedical Corp.
Chemistry · 63d
Cleared Nov 09, 1995
ABL SYSTEM 625, 615, 605
K954612
Radiometer America, Inc.
Chemistry · 35d
Cleared Mar 10, 1995
ABL5 BLOOD GAS SYSTEM
K943882
Radiometer America, Inc.
Chemistry · 213d
Cleared Mar 09, 1995
STAT PROFILE PLUS 10 ANALYZER
K936203
Nova Biomedical Corp.
Chemistry · 443d
Cleared Jan 30, 1995
CIBA CORNING 8-- SERIES CO-OXIMETER
K946206
Ciba Corning Diagnostics Corp.
Chemistry · 40d
Cleared Dec 29, 1994
STAT PROFILE ULTRA 11 ANALYZER
K943643
Nova Biomedical Corp.
Chemistry · 155d
Cleared Oct 20, 1994
AVL OPTI PH/BLOOD GAS ANALYZER
K944089
Avl Scientific Corp.
Chemistry · 59d
Cleared Aug 24, 1994
AVL COMPACT 1 PH/BLOOD GAS ANALYZER
K943570
Avl Scientific Corp.
Chemistry · 33d
Cleared Jul 28, 1994
AVL COMPACT 2 PH/BLOOD GAS ANALYZER
K942616
Avl Scientific Corp.
Chemistry · 56d
Cleared May 27, 1994
ABL SYSTEM 620
K935121
Radiometer America, Inc.
Chemistry · 212d
Cleared May 27, 1994
ABL5 BLOOD GAS SYSTEM
K935655
Radiometer America, Inc.
Chemistry · 184d
Cleared Mar 28, 1994
IL1430 BGELECTROLYTE ANALYZER
K935069
Instrumentation Laboratory CO
Chemistry · 154d
Cleared Feb 03, 1994
CIBA CORNING 248 PH/BLOOD GAS ANALYZER
K935830
Ciba Corning Diagnostics Corp.
Chemistry · 58d
Cleared Jan 03, 1994
860 MEASURMENT SYSTEM
K934907
Ciba Corning Diagnostics Corp.
Chemistry · 80d
Cleared Oct 14, 1993
AVL 9110PH ANALYZER
K932642
Avl Scientific Corp.
Chemistry · 134d
Cleared Feb 23, 1993
STAT PROFILE 9 ANALYZER
K924497
Nova Biomedical Corp.
Chemistry · 172d