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 Phoenix Diagnostics, Inc..

67
Total
67
Cleared
47d
Avg days
1977
Since
67 devices
49–67 of 67
Cleared Jan 28, 1982
PATHWAY PH BLOOD GAS CONTROL
K820103
Beckman Instruments, Inc.
Chemistry · 13d
Cleared Oct 02, 1981
SQC BUFFER
K812601
Transidyne General Corp.
Chemistry · 18d
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 Jan 26, 1981
RESPA-TROL
K810107
Intensive Technology, Inc.
Chemistry · 10d
Cleared Jul 21, 1980
BLOOD GAS CONTROL PROD. NO. BG-1, BG-2
K801449
Health Diagnostics Corp.
Chemistry · 28d
Cleared Dec 27, 1979
REFEREE BFT BLOOD FOR TONOMETRY
K792447
Analytical Products, Inc.
Chemistry · 27d
Cleared Nov 13, 1979
GAS-TRAK BLOOD GAS CONTROL
K792098
United Diagnostics, Inc.
Chemistry · 25d
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 Aug 16, 1979
MEDICOR QUALITY CONTROL BUFFER
K791287
Medicor USA , Ltd.
Chemistry · 37d
Cleared Jun 28, 1979
MULTECON BLOOD GAS CONTROL
K790813
Ortho Diagnostics, Inc.
Chemistry · 62d
Cleared Sep 20, 1978
BIOSCAN E12
K781421
Clinifax Industries, Ltd.
Chemistry · 34d
Cleared May 26, 1978
DYNEX BLOOD GAS QUALITY CONTROL SYS.
K780144
Analytical Products, Inc.
Chemistry · 122d
Cleared Aug 16, 1977
QUALICHECK TM
K771444
The London Co.
Chemistry · 15d
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