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

FDA 510(k) Cleared Controls For Blood-gases, (assayed And Unassayed) Devices (Product Code JJS)

67 devices
1–24 of 67
Cleared Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509
K022525
Bio-Rad
Immunology · 15d
Cleared Aug 15, 2002
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669
K022529
Bio-Rad
Chemistry · 15d
Cleared Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506
K003239
Bio-Rad
Chemistry · 44d
Cleared Nov 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623
K003242
Bio-Rad
Chemistry · 44d
Cleared Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578
K002865
Bio-Rad
Chemistry · 12d
Cleared Sep 25, 2000
LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574
K002866
Bio-Rad
Chemistry · 12d
Cleared Aug 30, 2000
LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513
K002535
Bio-Rad
Chemistry · 14d
Cleared Aug 30, 2000
LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER)
K002536
Bio-Rad
Chemistry · 14d
Cleared Aug 21, 2000
LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573
K002120
Bio-Rad
Chemistry · 39d
Cleared Jan 28, 1998
QUALICHECK5+ MODELS S7730, S7740, S7750, S7760
K980135
Radiometer America, Inc.
Chemistry · 13d
Cleared Aug 19, 1997
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
K972861
Instrumentation Laboratory CO
Chemistry · 15d
Cleared Jun 14, 1996
QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660)
K961354
Radiometer America, Inc.
Chemistry · 67d
Cleared Jun 14, 1996
MULTICHECK
K961355
Radiometer America, Inc.
Chemistry · 67d
Cleared Sep 05, 1995
QUALICHECK 4 GLUCOSE
K952637
Radiometer America, Inc.
Chemistry · 88d
Cleared Jul 06, 1995
STAT PROFILE ULTRA BLOOD GAS CONTROLS
K952477
Nova Biomedical Corp.
Chemistry · 37d
Cleared Jan 30, 1995
CERTAIN(R) ELITE LEVEL 1, 2 AND 3
K946224
Ciba Corning Diagnostics Corp.
Chemistry · 77d
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 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 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

About Product Code JJS - Regulatory Context