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
97–120 of 188
Cleared Nov 10, 1992
STATPAL II BLOOD GAS ANALYSIS SYSTEM
K922631
Ppg Industries, Inc.
Chemistry · 160d
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 Nov 29, 1991
STAT PAL SENSYR SYRINGE ASSEMBLY FOR USE W/STATPAL
K914560
Ppg Industries, Inc.
Chemistry · 45d
Cleared Oct 11, 1991
IL BG3 SYST, MODEL 1420, BLOOD GAS & PH TEST SYST
K913927
Instrumentation Laboratory CO
Chemistry · 38d
Cleared Dec 26, 1990
STATPAL BLOOD GAS MONITORING SYSTEM
K903965
Ppg Industries, Inc.
Chemistry · 120d
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 Jun 12, 1990
BLOOD GASES/PC02, PO2 ANALYSIS PRODUCTS
K902267
Phoenix Diagnostics, Inc.
Chemistry · 22d
Cleared Feb 01, 1990
AVL MODEL 995HB PH/BLOOD GAS ANALYZER
K895317
Avl Scientific Corp.
Chemistry · 156d
Cleared Oct 06, 1989
ABL500 BLOOD GAS SYSTEM
K895181
Radiometer America, Inc.
Chemistry · 56d
Cleared Jun 20, 1989
IL1400, BGELECTROLYTE ANALYZER
K890827
Instrumentation Laboratory CO
Chemistry · 119d
Cleared May 22, 1989
AVL MODEL 987 ELECTROLYTE ANALYZER
K891578
Avl Scientific Corp.
Chemistry · 63d
Cleared May 04, 1989
ELECTRODE A.PH BLOOD GAS B.ELECTROLYTE SYSTEMS
K884267
Alko Diagnostic Corp.
Chemistry · 205d
Cleared Dec 02, 1988
NOVA STAT PROFILE 7 ANALYZER QUALITY CONTROL MATER
K884143
Nova Biomedical Corp.
Chemistry · 63d
Cleared Jun 03, 1987
ANALYZER: NOVA STAT PROFILE 3 ANALYZER
K871397
Nova Biomedical Corp.
Chemistry · 57d
Cleared Mar 06, 1987
CIBA CORNING MODEL 278 PH/BLOOD GAS SYSTEM
K865036
Ciba Corning Diagnostics Corp.
Chemistry · 73d
Cleared Feb 04, 1987
STAT PROFILE 4 ANALYZER + QUALITY CONTROL MATERIAL
K864445
Nova Biomedical Corp.
Chemistry · 84d
Cleared Mar 05, 1986
ABL330 ACID BASE LABORATORY
K860057
Radiometer America, Inc.
Chemistry · 58d
Cleared Dec 09, 1985
LIFE WATCH RESPIRATORY MONITOR
K853840
The Perkin-Elmer Corp.
Chemistry · 84d
Cleared Dec 05, 1985
ANALYZER NOVA STAT PROFILE 2/QUALITY CONTROL MAT.
K854608
Nova Biomedical Corp.
Chemistry · 17d
Cleared Nov 12, 1985
ANALYZER: NOVA STAT PROFILE 1 QUA CON MAT: ELECT
K852790
Nova Biomedical Corp.
Hematology · 134d
Cleared Feb 01, 1985
MEMBRANE KITS-KC1, CO2 & 02 FOR INSTRUMENT-LAB
K844781
Shaban Mfg. Co.
Chemistry · 53d
Cleared Dec 10, 1984
ABL300 ACID BASE LABORATORY
K844295
Radiometer America, Inc.
Hematology · 34d