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
25–48 of 67
Cleared Apr 26, 1994
MULTICHECK(TM)
K935515
Radiometer America, Inc.
Chemistry · 162d
Cleared Sep 22, 1992
MICROBACT SOLID PLATE SYSTEMS
K923342
Radiometer America, Inc.
Microbiology · 98d
Cleared Jul 14, 1992
BLOOD GAS/ISE LINEARITY CONTROL
K920285
Phoenix Diagnostics, Inc.
Chemistry · 174d
Cleared Jun 30, 1992
RNA MEDICAL'S EQUIL 55
K922357
Bionostics, Inc.
Chemistry · 42d
Cleared Jan 02, 1992
QUALICHECK 4
K915399
Radiometer America, Inc.
Chemistry · 34d
Cleared Nov 02, 1990
QUALICHECK 3
K904733
Radiometer America, Inc.
Chemistry · 16d
Cleared Jun 06, 1990
BLOOD GAS CONTROLS
K901985
Phoenix Diagnostics, Inc.
Chemistry · 35d
Cleared May 31, 1990
BLOOD GAS/CO-OXIMETRY CONTROL
K901976
Phoenix Diagnostics, Inc.
Chemistry · 29d
Cleared May 31, 1990
CO-OXIMETER CONTROLS
K901986
Phoenix Diagnostics, Inc.
Chemistry · 29d
Cleared Aug 03, 1989
QUALICHECK 2
K894110
Radiometer America, Inc.
Chemistry · 52d
Cleared Dec 14, 1987
MULTI-FUNCTION BLOOD GAS CONTROL
K874408
Bionostics, Inc.
Chemistry · 47d
Cleared Jul 31, 1987
AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III
K872196
American Dade
Chemistry · 53d
Cleared Jan 14, 1987
BAYER HEALTHCARE RAPIDQC PLUS
K870036
Ciba Corning Diagnostics Corp.
Chemistry · 9d
Cleared Apr 07, 1986
MARQUEST QC-IV TONOMETER
K855024
Marquest Medical Products, Inc.
Chemistry · 111d
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 Oct 02, 1981
SQC BUFFER
K812601
Transidyne General Corp.
Chemistry · 18d