JJS · Class I · 21 CFR 862.1660

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

Leading manufacturers include Bio-Rad, Instrumentation Laboratory CO and Beckman Instruments, 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 Aug 19, 1997
IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3)
K972861
Instrumentation Laboratory CO
Chemistry · 15d
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 May 13, 1981
PH/BLOOD GAS CONTROL (ABC)
K811143
Instrumentation Laboratory CO
Chemistry · 16d
Cleared Jun 27, 1977
AQUEOUS PH/BLOOD GAS CONTROLS
K770228
Instrumentation Laboratory CO
Chemistry · 140d

About Product Code JJS - Regulatory Context