JJS · Class I · 21 CFR 862.1660

FDA Product Code JJS: Controls For Blood-gases, (assayed And Unassayed)

Leading manufacturers include Radiometer America, Inc., Bio-Rad and Bionostics, Inc..

67
Total
67
Cleared
47d
Avg days
1977
Since
67 devices
25–48 of 67
Cleared Jan 14, 1987
BAYER HEALTHCARE RAPIDQC PLUS
K870036
Ciba Corning Diagnostics Corp.
Chemistry · 9d
Cleared May 20, 1985
MULTI FUNCTION BLOOD GAS CONTROL
K851911
Bionostics, Inc.
Chemistry · 19d
Cleared Jun 14, 1984
BLOOD GAS CONTROL, LEVEL I(ACIDOSIS
K841783
Bionostics, Inc.
Chemistry · 45d
Cleared Nov 28, 1983
AQUEOUS BLOOD GAS CONTROL
K833146
Bionostics, Inc.
Chemistry · 74d
Cleared Aug 10, 1983
AQUEOUS BLOOD GAS CONTROL LEVEL I,II &
K832003
American Dade
Chemistry · 49d
Cleared Jul 18, 1983
CERTAIN HB CO-OXIMETER CONTROL
K832028
Corning Medical & Scientific
Hematology · 25d
Cleared Feb 28, 1983
REFEREE BLOOD GAS ANALYZER CONTROLS
K830181
Analytical Products, Inc.
Chemistry · 41d
Cleared Apr 16, 1982
CORNING CERTAIN TM
K820873
Corning Medical & Scientific
Chemistry · 18d
Cleared Mar 25, 1982
FETAL-TEK CONTROL MATURE
K820319
Helena Laboratories
Chemistry · 48d
Cleared Jan 28, 1982
PATHWAY PH BLOOD GAS CONTROL
K820103
Beckman Instruments, Inc.
Chemistry · 13d
Cleared Sep 23, 1981
PROTEIN-BASED BLOOD GAS CONTROL
K812541
American Dade
Chemistry · 19d
Cleared Sep 23, 1981
AQUEOUS BLOOD GAS CONTROLS
K812553
Fisher Scientific Co., LLC
Chemistry · 15d
Cleared May 13, 1981
PH/BLOOD GAS CONTROL (ABC)
K811143
Instrumentation Laboratory CO
Chemistry · 16d
Cleared Dec 27, 1979
REFEREE BFT BLOOD FOR TONOMETRY
K792447
Analytical Products, Inc.
Chemistry · 27d
Cleared Nov 13, 1979
FISHER DIAG. PRIME BLOOD GAS CONTROLS
K792143
Fisher Scientific Co., LLC
Chemistry · 20d
Cleared Nov 13, 1979
CORNING CONFIRM BLOOD GAS QUALITY CONTRO
K792180
Corning Medical & Scientific
Chemistry · 15d
Cleared May 26, 1978
DYNEX BLOOD GAS QUALITY CONTROL SYS.
K780144
Analytical Products, Inc.
Chemistry · 122d
Cleared Aug 02, 1977
WHOLE BLOOD GAS CONTROL
K770950
Dade, Baxter Travenol Diagnostics, Inc.
Hematology · 69d
Cleared Jul 15, 1977
TMA BICARBONATE DILUENT
K771044
Hyland Therapeutic Div., Travenol Laboratories
Chemistry · 35d
Cleared Jun 27, 1977
AQUEOUS PH/BLOOD GAS CONTROLS
K770228
Instrumentation Laboratory CO
Chemistry · 140d