Product code JJS
- Device name
- Controls For Blood-Gases, (Assayed And Unassayed)
- Medical specialty
- Clinical Chemistry
- Device class
- 1
- Regulation number
- 862.1660
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- N
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K152553 | CueSee Hypoxic | Eurotrol B.V. | 2016-04-22 |
| K150226 | Hematocrit and Metabolite QUALICHECK | Radiometer Medical Aps | 2015-05-13 |
| K130415 | HIGH METABOLITE QUALICHECK | Radiometer Medical Aps | 2013-03-26 |
| K130236 | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 | Radiometer Medical Aps | 2013-03-15 |
| K033063 | MISSION CONTROLS | Diamond Diagnostics, Inc. | 2003-12-12 |
| K022525 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (RADIOMETER 700 SERIES) LEVELS, 1,2 AND 3, MODEL 507, 508, 509 | Bio-Rad | 2002-08-15 |
| K022529 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL SYNTHESIS SERIES) LEVELS 1,2, AND 3, MODELS 667,668,669 | Bio-Rad | 2002-08-15 |
| K003239 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 | Bio-Rad | 2000-11-30 |
| K003242 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 | Bio-Rad | 2000-11-30 |
| K002865 | LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 | Bio-Rad | 2000-09-25 |
| K002866 | LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 | Bio-Rad | 2000-09-25 |
| K002535 | LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 | Bio-Rad | 2000-08-30 |
| K002536 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) | Bio-Rad | 2000-08-30 |
| K002120 | LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 | Bio-Rad | 2000-08-21 |
| K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 | Radiometer America, Inc. | 1998-01-28 |
| K972861 | IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) | Instrumentation Laboratory CO | 1997-08-19 |
| K961355 | MULTICHECK | Radiometer America, Inc. | 1996-06-14 |
| K961354 | QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) | Radiometer America, Inc. | 1996-06-14 |
| K961441 | TONOMETERED SLAINE BLOOD GAS CONTROL | Instrumentarium Corp. | 1996-04-30 |
| K955340 | EUROTROL GAS - ISE CONTROL | Direct Solutions | 1995-12-26 |
| K952637 | QUALICHECK 4 GLUCOSE | Radiometer America, Inc. | 1995-09-05 |
| K952477 | STAT PROFILE ULTRA BLOOD GAS CONTROLS | Nova Biomedical Corp. | 1995-07-06 |
| K950902 | ALKO TONOMETERED SALINE CONTROL | Alko Diagnostic Corp. | 1995-03-30 |
| K946224 | CERTAIN(R) ELITE LEVEL 1, 2 AND 3 | Ciba Corning Diagnostics Corp. | 1995-01-30 |
| K945860 | SPECTRUM CO-OXIMETER LINEARITY CONTROL | Phoenix Diagnostics, Inc. | 1995-01-17 |
| K935515 | MULTICHECK(TM) | Radiometer America, Inc. | 1994-04-26 |
| K923342 | MICROBACT SOLID PLATE SYSTEMS | Radiometer America, Inc. | 1992-09-22 |
| K920285 | BLOOD GAS/ISE LINEARITY CONTROL | Phoenix Diagnostics, Inc. | 1992-07-14 |
| K922357 | RNA MEDICAL'S EQUIL 55 | Bionostics, Inc. | 1992-06-30 |
| K915399 | QUALICHECK 4 | Radiometer America, Inc. | 1992-01-02 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08718734963035 | CueSee® Hyperbaric | Eurotrol B.V. | 2026-01-07 |
| 10852676007121 | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | 2023-08-09 |
| 10852676007138 | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | 2023-08-09 |
| 10852676007145 | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | 2023-08-09 |
| 10852676007152 | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | 2023-08-09 |
| 10852676007169 | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | 2023-08-09 |
| 10852676007176 | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | 2023-08-09 |
| 10852676007183 | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | 2023-08-09 |
| 10852676007190 | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | 2023-08-09 |
| 10852676007206 | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | 2023-08-09 |
| 10852676007213 | Phoenix Diagnostics | PHOENIX DIAGNOSTICS, INC. | 2023-08-09 |
| 08718734961093 | CueSee® Hyperbaric X-High | Eurotrol B.V. | 2021-06-08 |
| 08718734960652 | CueSee® Hypoxic | Eurotrol B.V. | 2020-10-08 |
| 00380740156268 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740156282 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740156299 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740156312 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740156374 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00380740156411 | ARCHITECT | ABBOTT LABORATORIES | 2020-03-03 |
| 00385480364591 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480248198 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480359429 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480362597 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-20 |
| 00385480364614 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480364577 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480364553 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00385480364539 | STAT PROFILE | NOVA BIOMEDICAL CORPORATION | 2016-09-16 |
| 00380740054243 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740054151 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |
| 00380740044862 | ARCHITECT | ABBOTT LABORATORIES | 2016-09-09 |