JJS · Class I · 21 CFR 862.1660

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

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

67
Total
67
Cleared
47d
Avg days
1977
Since
67 devices
49–67 of 67
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 Jun 28, 1979
MULTECON BLOOD GAS CONTROL
K790813
Ortho Diagnostics, Inc.
Chemistry · 62d
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