Controls For Blood-Gases, (Assayed And Unassayed)
FDA product code JJS · Class I (low risk) · 21 CFR 862.1660 · Clinical Chemistry
67510(k) clearances
0PMA approvals
1recalls
Manufacturers
- Radiometer America, Inc. 9
- Bio-Rad 9
- Phoenix Diagnostics, Inc. 5
- Bionostics, Inc. 5
- Corning Medical & Scientific 3
- Radiometer Medical Aps 3
- American Dade 3
- Instrumentation Laboratory CO 3
- Analytical Products, Inc. 3
- United Diagnostics, Inc. 2
- Fisher Scientific Co., LLC 2
- Ciba Corning Diagnostics Corp. 2
- Medicor USA , Ltd. 1
- Health Diagnostics Corp. 1
- Intensive Technology, Inc. 1
- Eurotrol B.V. 1
- Transidyne General Corp. 1
- Clinifax Industries, Ltd. 1
- The London Co. 1
- Dade, Baxter Travenol Diagnostics, Inc. 1
510(k) clearances
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K152553 | CueSee HypoxicJJS · Traditional | Eurotrol B.V. | 04/22/2016SE |
| K150226 | Hematocrit and Metabolite QUALICHECKJJS · Traditional | Radiometer Medical Aps | 05/13/2015SE |
| K130415 | High Metabolite QualicheckJJS · Traditional | Radiometer Medical Aps | 03/26/2013SE |
| K130236 | Range + Qualicheck Level 1, Range + Qualicheck Level 2, Range + Qualicheck Level 3JJS · Traditional | Radiometer Medical Aps | 03/15/2013SE |
| K033063 | Mission ControlsJJS · Traditional | Diamond Diagnostics, Inc. | 12/12/2003SE |
| K022529 | Liquichek Blood Gas Plus Co-Oximeter Control (Il Synthesis Series) Levels 1,2, and 3…JJS · Traditional | Bio-Rad | 08/15/2002SE |
| K022525 | Liquichek Blood Gas Plus Co-Oximeter Control (Radiometer 700 Series) Levels, 1,2 and 3…JJS · Traditional | Bio-Rad | 08/15/2002SE |
| K003242 | Liquichek Blood Gas Plus Co-Oximeter Control (Il), Model 621,622,623JJS · Traditional | Bio-Rad | 11/30/2000SE |
| K003239 | Liquichek Blood Gas Plus Co-Oximeter Control (800 Series), MODEL504,505,506JJS · Traditional | Bio-Rad | 11/30/2000SE |
| K002866 | Liquichek Blood Gas Plus E Control Level 4, Model 574JJS · Traditional | Bio-Rad | 09/25/2000SE |
| K002865 | Liquichek Blood Gas Plus E Control, Model 576, 577, 578JJS · Traditional | Bio-Rad | 09/25/2000SE |
| K002536 | Liquichek Blood Gas Plus Co-Oximeter Control, Models 637, 638, 639 (Radiometer)JJS · Traditional | Bio-Rad | 08/30/2000SE |
| K002535 | Liquichec Blood Gas Pluse Control with Glucose, Model 511, 512, 513JJS · Traditional | Bio-Rad | 08/30/2000SE |
| K002120 | Liquichek Blood Gas Control, Model 571, 572, 573JJS · Traditional | Bio-Rad | 08/21/2000SE |
| K980135 | QUALICHECK5+ Models S7730, S7740, S7750, S7760JJS · Traditional | Radiometer America, Inc. | 01/28/1998SE |
| K972861 | Il Test Contril Spectrum (Levels 1, 2 and 3)JJS · Traditional | Instrumentation Laboratory CO | 08/19/1997SE |
| K961355 | MulticheckJJS · Traditional | Radiometer America, Inc. | 06/14/1996SE |
| K961354 | Qualicheck 4 METABOLITE(S3630,S3640,S3650,S3660)JJS · Traditional | Radiometer America, Inc. | 06/14/1996SE |
| K961441 | Tonometered Slaine Blood Gas ControlJJS · Traditional | Instrumentarium Corp. | 04/30/1996SE |
| K955340 | Eurotrol Gas - Ise ControlJJS · Traditional | Direct Solutions | 12/26/1995SE |
| K952637 | Qualicheck 4 GlucoseJJS · Traditional | Radiometer America, Inc. | 09/05/1995SE |
| K952477 | Stat Profile Ultra Blood Gas ControlsJJS · Traditional | Nova Biomedical Corp. | 07/06/1995SE |
| K950902 | Alko Tonometered Saline ControlJJS · Traditional | Alko Diagnostic Corp. | 03/30/1995SE |
| K946224 | Certain(R) Elite Level 1, 2 and 3JJS · Traditional | Ciba Corning Diagnostics Corp. | 01/30/1995SE |
| K945860 | Spectrum Co-Oximeter Linearity ControlJJS · Traditional | Phoenix Diagnostics, Inc. | 01/17/1995SE |
| K935515 | Multicheck(Tm)JJS · Traditional | Radiometer America, Inc. | 04/26/1994SE |
| K923342 | Microbact Solid Plate SystemsJJS · Traditional | Radiometer America, Inc. | 09/22/1992SE |
| K920285 | Blood Gas/Ise Linearity ControlJJS · Traditional | Phoenix Diagnostics, Inc. | 07/14/1992SE |
| K922357 | RNA Medical's Equil 55JJS · Traditional | Bionostics, Inc. | 06/30/1992SE |
| K915399 | Qualicheck 4JJS · Traditional | Radiometer America, Inc. | 01/02/1992SE |
| K904733 | Qualicheck 3JJS · Traditional | Radiometer America, Inc. | 11/02/1990SE |
| K901985 | Blood Gas ControlsJJS · Traditional | Phoenix Diagnostics, Inc. | 06/06/1990SE |
| K901986 | Co-Oximeter ControlsJJS · Traditional | Phoenix Diagnostics, Inc. | 05/31/1990SE |
| K901976 | Blood Gas/Co-Oximetry ControlJJS · Traditional | Phoenix Diagnostics, Inc. | 05/31/1990SE |
| K894110 | Qualicheck 2JJS · Traditional | Radiometer America, Inc. | 08/03/1989SE |
| K874408 | Multi-Function Blood Gas ControlJJS · Traditional | Bionostics, Inc. | 12/14/1987SE |
| K872196 | Aqueous Blood Gas/Electrolyte Contr Lev I,Ii & IIIJJS · Traditional | American Dade | 07/31/1987SE |
| K870036 | Bayer Healthcare Rapidqc PlusJJS · Traditional | Ciba Corning Diagnostics Corp. | 01/14/1987SE |
| K855024 | Marquest Qc-Iv TonometerJJS · Traditional | Marquest Medical Products, Inc. | 04/07/1986SE |
| K851911 | Multi Function Blood Gas ControlJJS · Traditional | Bionostics, Inc. | 05/20/1985SE |
| K841783 | Blood Gas Control, Level I(AcidosisJJS · Traditional | Bionostics, Inc. | 06/14/1984SE |
| K833146 | Aqueous Blood Gas ControlJJS · Traditional | Bionostics, Inc. | 11/28/1983SE |
| K832003 | Aqueous Blood Gas Control Level I,Ii &JJS · Traditional | American Dade | 08/10/1983SE |
| K832028 | Certain HB Co-Oximeter ControlJJS · Traditional | Corning Medical & Scientific | 07/18/1983SE |
| K830181 | Referee Blood Gas Analyzer ControlsJJS · Traditional | Analytical Products, Inc. | 02/28/1983SE |
| K820873 | Corning Certain TMJJS · Traditional | Corning Medical & Scientific | 04/16/1982SE |
| K820705 | Gas-Trak 2 Synthetic Blood Gas ControlJJS · Traditional | United Diagnostics, Inc. | 04/01/1982SE |
| K820319 | Fetal-Tek Control MatureJJS · Traditional | Helena Laboratories | 03/25/1982SE |
| K820103 | Pathway PH Blood Gas ControlJJS · Traditional | Beckman Instruments, Inc. | 01/28/1982SE |
| K812601 | SQC BufferJJS · Traditional | Transidyne General Corp. | 10/02/1981SE |
| K812553 | Aqueous Blood Gas ControlsJJS · Traditional | Fisher Scientific Co., LLC | 09/23/1981SE |
| K812541 | Protein-Based Blood Gas ControlJJS · Traditional | American Dade | 09/23/1981SE |
| K811143 | Ph/Blood Gas Control (Abc)JJS · Traditional | Instrumentation Laboratory CO | 05/13/1981SE |
| K810107 | Respa-TrolJJS · Traditional | Intensive Technology, Inc. | 01/26/1981SE |
| K801449 | Blood Gas Control Prod. No. BG-1, BG-2JJS · Traditional | Health Diagnostics Corp. | 07/21/1980SE |
| K792447 | Referee BFT Blood for TonometryJJS · Traditional | Analytical Products, Inc. | 12/27/1979SE |
| K792180 | Corning Confirm Blood Gas Quality ControJJS · Traditional | Corning Medical & Scientific | 11/13/1979SE |
| K792143 | Fisher Diag. Prime Blood Gas ControlsJJS · Traditional | Fisher Scientific Co., LLC | 11/13/1979SE |
| K792098 | Gas-Trak Blood Gas ControlJJS · Traditional | United Diagnostics, Inc. | 11/13/1979SE |
| K791287 | Medicor Quality Control BufferJJS · Traditional | Medicor USA , Ltd. | 08/16/1979SE |
| K790813 | Multecon Blood Gas ControlJJS · Traditional | Ortho Diagnostics, Inc. | 06/28/1979SE |
| K781421 | Bioscan E12JJS · Traditional | Clinifax Industries, Ltd. | 09/20/1978SE |
| K780144 | Dynex Blood Gas Quality Control Sys.JJS · Traditional | Analytical Products, Inc. | 05/26/1978SE |
| K771444 | Qualicheck TMJJS · Traditional | The London Co. | 08/16/1977SE |
| K770950 | Whole Blood Gas ControlJJS · Traditional | Dade, Baxter Travenol Diagnostics, Inc. | 08/02/1977SE |
| K771044 | Tma Bicarbonate DiluentJJS · Traditional | Hyland Therapeutic Div., Travenol Laboratories | 07/15/1977SE |
| K770228 | Aqueous Ph/Blood Gas ControlsJJS · Traditional | Instrumentation Laboratory CO | 06/27/1977SE |
Recalls
| Recall | Product | Firm | Initiated |
|---|---|---|---|
| Z-3237-2017 Class II | AutoCheck5+, Level 2, specifically designed for Radiometer Americas blood gas analyzers…Radiometer has recently become aware that a few of the AUTOCHECK 5+ level 2 ampoules, will give incorrect… | Radiometer America Inc | 09/07/2017Terminated |