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
49–72 of 188
Cleared Oct 06, 1997
ABL555 BLOOD GAS, ELECTROLYTE & METABOLITE SYSTEM
K973367
Radiometer America, Inc.
Chemistry · 28d
Cleared May 09, 1997
STAT PROFILE ULTRA M ANALYZER
K970710
Nova Biomedical Corp.
Chemistry · 72d
Cleared Nov 13, 1996
IL SYNTHESIS
K963800
Instrumentation Laboratory CO
Chemistry · 51d
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 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 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 Feb 23, 1993
STAT PROFILE 9 ANALYZER
K924497
Nova Biomedical Corp.
Chemistry · 172d
Cleared Aug 28, 1992
ABL50 BLOOD GAS SYSTEM
K922922
Radiometer America, Inc.
Chemistry · 72d
Cleared Jan 28, 1992
ABL505 BLOOD GAS & ELECTROLYTE SYSTEM
K914166
Radiometer America, Inc.
Chemistry · 133d
Cleared Oct 11, 1991
IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST
K913927
Instrumentation Laboratory CO
Chemistry · 38d
Cleared Dec 13, 1990
ABL510 BLOOD GAS SYSTEM
K904513
Radiometer America, Inc.
Chemistry · 72d
Cleared Sep 27, 1990
CIBA CORNING MODEL 238 PH/ BLOOD GAS ANALYZER
K904188
Ciba Corning Diagnostics Corp.
Chemistry · 15d
Cleared Oct 06, 1989
ABL500 BLOOD GAS SYSTEM
K895181
Radiometer America, Inc.
Chemistry · 56d