FDA Product Code
FDA Product Code JJS — Clearance Directory
- Device Class
- Class I
- Assigned Panel
- Clinical Chemistry
- 21 CFR Citation
- 862.1660
510(k) Clearances — 67 records
| K-Number | Device Name | Applicant | Decision Date | Clearance Type | Summary |
|---|---|---|---|---|---|
| K152553 | CueSee Hypoxic | Eurotrol B.V. | 2016-04-22 | Traditional | PDF ↗ |
| K150226 | Hematocrit and Metabolite QUALICHECK | Radiometer Medical Aps | 2015-05-13 | Traditional | PDF ↗ |
| K130415 | HIGH METABOLITE QUALICHECK | Radiometer Medical Aps | 2013-03-26 | Traditional | PDF ↗ |
| K130236 | RANGE + QUALICHECK LEVEL 1, RANGE + QUALICHECK LEVEL 2, RANGE + QUALICHECK LEVEL 3 | Radiometer Medical Aps | 2013-03-15 | Traditional | PDF ↗ |
| K033063 | MISSION CONTROLS | Diamond Diagnostics, Inc. | 2003-12-12 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| 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 | Traditional | PDF ↗ |
| K003239 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (800 SERIES), MODEL504,505,506 | Bio-Rad | 2000-11-30 | Traditional | PDF ↗ |
| K003242 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL (IL), MODEL 621,622,623 | Bio-Rad | 2000-11-30 | Traditional | PDF ↗ |
| K002866 | LIQUICHEK BLOOD GAS PLUS E CONTROL LEVEL 4, MODEL 574 | Bio-Rad | 2000-09-25 | Traditional | PDF ↗ |
| K002865 | LIQUICHEK BLOOD GAS PLUS E CONTROL, MODEL 576, 577, 578 | Bio-Rad | 2000-09-25 | Traditional | PDF ↗ |
| K002535 | LIQUICHEC BLOOD GAS PLUSE CONTROL WITH GLUCOSE, MODEL 511, 512, 513 | Bio-Rad | 2000-08-30 | Traditional | PDF ↗ |
| K002536 | LIQUICHEK BLOOD GAS PLUS CO-OXIMETER CONTROL, MODELS 637, 638, 639 (RADIOMETER) | Bio-Rad | 2000-08-30 | Traditional | PDF ↗ |
| K002120 | LIQUICHEK BLOOD GAS CONTROL, MODEL 571, 572, 573 | Bio-Rad | 2000-08-21 | Traditional | PDF ↗ |
| K980135 | QUALICHECK5+ MODELS S7730, S7740, S7750, S7760 | Radiometer America, Inc. | 1998-01-28 | Traditional | PDF ↗ |
| K972861 | IL TEST CONTRIL SPECTRUM (LEVELS 1, 2 AND 3) | Instrumentation Laboratory CO | 1997-08-19 | Traditional | PDF ↗ |
| K961355 | MULTICHECK | Radiometer America, Inc. | 1996-06-14 | Traditional | PDF ↗ |
| K961354 | QUALICHECK 4 METABOLITE(S3630,S3640,S3650,S3660) | Radiometer America, Inc. | 1996-06-14 | Traditional | PDF ↗ |
| K961441 | TONOMETERED SLAINE BLOOD GAS CONTROL | Instrumentarium Corp. | 1996-04-30 | Traditional | PDF ↗ |
| K955340 | EUROTROL GAS - ISE CONTROL | Direct Solutions | 1995-12-26 | Traditional | PDF ↗ |
| K952637 | QUALICHECK 4 GLUCOSE | Radiometer America, Inc. | 1995-09-05 | Traditional | PDF ↗ |
| K952477 | STAT PROFILE ULTRA BLOOD GAS CONTROLS | Nova Biomedical Corp. | 1995-07-06 | Traditional | PDF ↗ |
| K950902 | ALKO TONOMETERED SALINE CONTROL | Alko Diagnostic Corp. | 1995-03-30 | Traditional | PDF ↗ |
| K946224 | CERTAIN(R) ELITE LEVEL 1, 2 AND 3 | Ciba Corning Diagnostics Corp. | 1995-01-30 | Traditional | PDF ↗ |
| K945860 | SPECTRUM CO-OXIMETER LINEARITY CONTROL | Phoenix Diagnostics, Inc. | 1995-01-17 | Traditional | PDF ↗ |
| K935515 | MULTICHECK(TM) | Radiometer America, Inc. | 1994-04-26 | Traditional | PDF ↗ |
| K923342 | MICROBACT SOLID PLATE SYSTEMS | Radiometer America, Inc. | 1992-09-22 | Traditional | PDF ↗ |
| K920285 | BLOOD GAS/ISE LINEARITY CONTROL | Phoenix Diagnostics, Inc. | 1992-07-14 | Traditional | PDF ↗ |
| K922357 | RNA MEDICAL'S EQUIL 55 | Bionostics, Inc. | 1992-06-30 | Traditional | PDF ↗ |
| K915399 | QUALICHECK 4 | Radiometer America, Inc. | 1992-01-02 | Traditional | PDF ↗ |
| K904733 | QUALICHECK 3 | Radiometer America, Inc. | 1990-11-02 | Traditional | PDF ↗ |
| K901985 | BLOOD GAS CONTROLS | Phoenix Diagnostics, Inc. | 1990-06-06 | Traditional | PDF ↗ |
| K901976 | BLOOD GAS/CO-OXIMETRY CONTROL | Phoenix Diagnostics, Inc. | 1990-05-31 | Traditional | PDF ↗ |
| K901986 | CO-OXIMETER CONTROLS | Phoenix Diagnostics, Inc. | 1990-05-31 | Traditional | PDF ↗ |
| K894110 | QUALICHECK 2 | Radiometer America, Inc. | 1989-08-03 | Traditional | PDF ↗ |
| K874408 | MULTI-FUNCTION BLOOD GAS CONTROL | Bionostics, Inc. | 1987-12-14 | Traditional | PDF ↗ |
| K872196 | AQUEOUS BLOOD GAS/ELECTROLYTE CONTR LEV I,II & III | American Dade | 1987-07-31 | Traditional | PDF ↗ |
| K870036 | BAYER HEALTHCARE RAPIDQC PLUS | Ciba Corning Diagnostics Corp. | 1987-01-14 | Traditional | PDF ↗ |
| K855024 | MARQUEST QC-IV TONOMETER | Marquest Medical Products, Inc. | 1986-04-07 | Traditional | PDF ↗ |
| K851911 | MULTI FUNCTION BLOOD GAS CONTROL | Bionostics, Inc. | 1985-05-20 | Traditional | PDF ↗ |
| K841783 | BLOOD GAS CONTROL, LEVEL I(ACIDOSIS | Bionostics, Inc. | 1984-06-14 | Traditional | PDF ↗ |
| K833146 | AQUEOUS BLOOD GAS CONTROL | Bionostics, Inc. | 1983-11-28 | Traditional | PDF ↗ |
| K832003 | AQUEOUS BLOOD GAS CONTROL LEVEL I,II & | American Dade | 1983-08-10 | Traditional | PDF ↗ |
| K832028 | CERTAIN HB CO-OXIMETER CONTROL | Corning Medical & Scientific | 1983-07-18 | Traditional | PDF ↗ |
| K830181 | REFEREE BLOOD GAS ANALYZER CONTROLS | Analytical Products, Inc. | 1983-02-28 | Traditional | PDF ↗ |
| K820873 | CORNING CERTAIN TM | Corning Medical & Scientific | 1982-04-16 | Traditional | PDF ↗ |
| K820705 | GAS-TRAK 2 SYNTHETIC BLOOD GAS CONTROL | United Diagnostics, Inc. | 1982-04-01 | Traditional | PDF ↗ |
| K820319 | FETAL-TEK CONTROL MATURE | Helena Laboratories | 1982-03-25 | Traditional | PDF ↗ |
| K820103 | PATHWAY PH BLOOD GAS CONTROL | Beckman Instruments, Inc. | 1982-01-28 | Traditional | PDF ↗ |
| K812601 | SQC BUFFER | Transidyne General Corp. | 1981-10-02 | Traditional | PDF ↗ |
| K812553 | AQUEOUS BLOOD GAS CONTROLS | Fisher Scientific Co., LLC | 1981-09-23 | Traditional | PDF ↗ |
| K812541 | PROTEIN-BASED BLOOD GAS CONTROL | American Dade | 1981-09-23 | Traditional | PDF ↗ |
| K811143 | PH/BLOOD GAS CONTROL (ABC) | Instrumentation Laboratory CO | 1981-05-13 | Traditional | PDF ↗ |
| K810107 | RESPA-TROL | Intensive Technology, Inc. | 1981-01-26 | Traditional | PDF ↗ |
| K801449 | BLOOD GAS CONTROL PROD. NO. BG-1, BG-2 | Health Diagnostics Corp. | 1980-07-21 | Traditional | PDF ↗ |
| K792447 | REFEREE BFT BLOOD FOR TONOMETRY | Analytical Products, Inc. | 1979-12-27 | Traditional | PDF ↗ |
| K792143 | FISHER DIAG. PRIME BLOOD GAS CONTROLS | Fisher Scientific Co., LLC | 1979-11-13 | Traditional | PDF ↗ |
| K792098 | GAS-TRAK BLOOD GAS CONTROL | United Diagnostics, Inc. | 1979-11-13 | Traditional | PDF ↗ |
| K792180 | CORNING CONFIRM BLOOD GAS QUALITY CONTRO | Corning Medical & Scientific | 1979-11-13 | Traditional | PDF ↗ |
| K791287 | MEDICOR QUALITY CONTROL BUFFER | Medicor USA , Ltd. | 1979-08-16 | Traditional | PDF ↗ |
| K790813 | MULTECON BLOOD GAS CONTROL | Ortho Diagnostics, Inc. | 1979-06-28 | Traditional | PDF ↗ |
| K781421 | BIOSCAN E12 | Clinifax Industries, Ltd. | 1978-09-20 | Traditional | PDF ↗ |
| K780144 | DYNEX BLOOD GAS QUALITY CONTROL SYS. | Analytical Products, Inc. | 1978-05-26 | Traditional | PDF ↗ |
| K771444 | QUALICHECK TM | The London Co. | 1977-08-16 | Traditional | PDF ↗ |
| K770950 | WHOLE BLOOD GAS CONTROL | Dade, Baxter Travenol Diagnostics, Inc. | 1977-08-02 | Traditional | PDF ↗ |
| K771044 | TMA BICARBONATE DILUENT | Hyland Therapeutic Div., Travenol Laboratories | 1977-07-15 | Traditional | PDF ↗ |
| K770228 | AQUEOUS PH/BLOOD GAS CONTROLS | Instrumentation Laboratory CO | 1977-06-27 | Traditional | PDF ↗ |
Product code JJS · Class I · Clinical Chemistry. Data: openFDA.