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
73–96 of 188
Cleared Jun 20, 1989
IL1400, BGELECTROLYTE ANALYZER
K890827
Instrumentation Laboratory CO
Chemistry · 119d
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
Cleared May 25, 1984
COMPONENTS FOR PARTIAL PRESSURE ELEE
K841609
Shaban Mfg. Co.
Chemistry · 46d
Cleared Apr 17, 1984
POTASSIUM CHLORIDE TABLETS
K840843
Bionostics, Inc.
Chemistry · 53d
Cleared Mar 30, 1984
PARTIAL PRESS. ELECTRODE MEASUREMENT
K840468
Shaban Mfg. Co.
Chemistry · 56d
Cleared Mar 23, 1984
FLUSH SOLUTION CONCENTRATE-BLOOD GAS
K840300
Bionostics, Inc.
Chemistry · 59d
Cleared Oct 28, 1983
ELECTRODES FOR BLOOD GAS ANALYZERS
K832981
Analytical Products, Inc.
Chemistry · 56d
Cleared Oct 14, 1983
REFEREE BLOOD GAS ANALYZER-ELECTRODES
K832779
Analytical Products, Inc.
Chemistry · 59d
Cleared Jun 16, 1983
CALIBRATING SOLUTION FOR ABL-1 & 2
K831018
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
PH 6.838 REF. BUFFER
K831019
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
CALIBRATING SOLUTION FOR ABL-1 & 2
K831021
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
ELECTROLYTE PO2 FOR OXYGEN ELECTRODES
K831024
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 16, 1983
ELECTROLYLE CARBON DIOXIDE ELECTRODES
K831025
Fisher Scientific Co., LLC
Chemistry · 78d
Cleared Jun 15, 1983
REFERENCE BUFFER PH 7.382
K831023
Fisher Scientific Co., LLC
Chemistry · 77d
Cleared Jun 08, 1983
DIAGNOSTICS PCO2 ELECTROLYTE W/CARBON
K831012
Fisher Scientific Co., LLC
Chemistry · 70d