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

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

67 devices
1–24 of 67
Cleared Apr 22, 2016
CueSee Hypoxic
K152553
Eurotrol B.V.
Chemistry · 227d
Cleared May 13, 2015
Hematocrit and Metabolite QUALICHECK
K150226
Radiometer Medical Aps
Chemistry · 100d
Cleared Mar 26, 2013
HIGH METABOLITE QUALICHECK
K130415
Radiometer Medical Aps
Chemistry · 35d
Cleared Mar 15, 2013
RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3
K130236
Radiometer Medical Aps
Chemistry · 44d
Cleared Dec 12, 2003
MISSION CONTROLS
K033063
Diamond Diagnostics, Inc.
Chemistry · 74d
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 Apr 30, 1996
TONOMETERED SLAINE BLOOD GAS CONTROL
K961441
Instrumentarium Corp.
Chemistry · 15d
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 Mar 30, 1995
ALKO TONOMETERED SALINE CONTROL
K950902
Alko Diagnostic Corp.
Chemistry · 30d
Cleared Jan 30, 1995
CERTAIN(R) ELITE LEVEL 1, 2 AND 3
K946224
Ciba Corning Diagnostics Corp.
Chemistry · 77d
Cleared Jan 17, 1995
SPECTRUM CO-OXIMETER LINEARITY CONTROL
K945860
Phoenix Diagnostics, Inc.
Chemistry · 47d

About Product Code JJS - Regulatory Context