Product code CGS
- Device name
- Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes
- Medical specialty
- Clinical Chemistry
- Device class
- 2
- Regulation number
- 862.1215
- Review panel
- CH
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K191296 | Pointe Scientific Creatinine Kinase (CK) Reagent Set | Medtest DX | 2020-08-11 |
| K182702 | SEKURE Creatine Kinase Assay | Sekisui Diagnostics P.E.I., Inc. | 2019-04-17 |
| K160724 | ADVIA Chemistry Creatine Kinase (CK_L) Assay, ADVIA Chemistry Enzyme 3 Calibrator | Siemens Healthcare Diagnostics, Inc. | 2016-09-07 |
| K123977 | RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR | Randox Laboratories, Ltd. | 2013-11-21 |
| K112416 | CPK REAGENT | Vital Diagnostics (Manufacturing) Ptyltd | 2011-11-09 |
| K083465 | DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE | Siemens Healthcare Diagnostics | 2009-02-27 |
| K081731 | DIMENSION CKI FLEX REAGENT CARTRIDGE, DIMENSION MBI FLEX REAGENT CARTRIDGE, AND CKI/MBI CALIBRATOR, MODELS DF38, DF32 | Siemens Healthcare Diagnostics | 2008-08-29 |
| K072548 | CREATINE KINASE LIQUID REAGENT, MODEL C519-440 | Teco Diagnostics | 2008-04-18 |
| K062737 | CARDIAC MARKERS ON ABX PENTRA 400 CLINICAL CHEMISTRY ANALYZER | Horiba Abx | 2007-06-12 |
| K051648 | SPOTCHEM II INOGANIC PHOSPHORUS, CPK AND URIC ACID TESTS | Arkray, Inc. | 2006-01-31 |
| K043202 | OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279 | Olympus America, Inc. | 2004-12-23 |
| K021332 | WIENER LAB. CK-NAC UV UNITEST, WIENER LAB. CK-NAC UV AA, WIENER LAB. CK-NAC UV AA, WIENER LAB.NAC UV AA LIQUIDA | Wiener Laboratories Saic | 2002-07-03 |
| K013912 | CREATINE KINASE (CK-NAC) | Jas Diagnostics, Inc. | 2002-01-18 |
| K012474 | ATAC PAK CPK REAGENT KIT | Elan Holdings, Inc. | 2001-10-03 |
| K994189 | OLYMPUS CREATINE KINASE REAGENT OSR6179/6279 | Olympus Diagnostica GmbH | 2000-01-20 |
| K992148 | HYDRAGEL-MINI ISO-CK KIT, HYDRAGEL ISO-CK KIT, HYDRAGEL 7 IS0-CK KIT, HYDRAGEL ISO-CK 15/30 KIT | Morax | 1999-12-29 |
| K983070 | CK | Abbott Laboratories | 1999-02-16 |
| K981218 | CREATINE KINASE (CK) | Abbott Laboratories | 1998-05-01 |
| K980900 | N-ASSAY CPK-L | Crestat Diagnostics, Inc. | 1998-03-26 |
| K973999 | CREATINE KINASE-SL ASSAY, CATALOGUE NUMBER 326-10, 326-30 | Diagnostic Chemicals , Ltd. | 1998-03-11 |
| K974833 | CK-NAC REAGENT | Intersect Systems, Inc. | 1998-02-13 |
| K972155 | CREATINE KINASE (CK) | Stanbio Laboratory | 1997-07-17 |
| K971566 | CREATINE KINASE-MB REAGENT SET | Horizon Diagnostics, Inc. | 1997-07-14 |
| K971396 | CK REAGENT | Carolina Liquid Chemistries Corp. | 1997-05-29 |
| K962247 | HICHEM CK/NAC REAGENT KIT | Elan Pharma, Inc. | 1996-08-15 |
| K951223 | CK-MB (NAC-ACT) | Randox Laboratories, Ltd. | 1995-12-26 |
| K952745 | CREATINE KINASE REAGENT SYSTEM | Medical Diagnostic Technologies, Inc. | 1995-08-11 |
| K952646 | IL TEST CK-MB | Instrumentation Laboratory CO | 1995-08-04 |
| K950177 | CK QVET | Prisma Systems | 1995-03-03 |
| K942773 | CK-MB ASSAY, CATALOGUE NUMBER 317-10 | Diagnostic Chemicals , Ltd. | 1994-08-24 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00850053916090 | IDG/Sanzay | IDG/SANZAY Corporation | 2024-01-09 |
| 10673486001655 | Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set | TECO DIAGNOSTICS | 2023-11-17 |
| 10673486001648 | Teco Diagnostics Creatine Kinase-MB (CK-MB) Reagent Set | TECO DIAGNOSTICS | 2023-11-17 |
| 10673486001501 | Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set | TECO DIAGNOSTICS | 2023-07-27 |
| 10673486001617 | Teco Diagnostics Creatine Kinase (CK-NAC) Liquid Reagent TC Matrix | TECO DIAGNOSTICS | 2023-07-27 |
| 10673486001594 | Teco Diagnostics Creatine Kinase (CK-NAC) Liquid Reagent | TECO DIAGNOSTICS | 2023-07-27 |
| 10673486001495 | Teco Diagnostics Creatine Kinase (CK-NAC) Reagent Set | TECO DIAGNOSTICS | 2023-07-27 |
| 00811727016096 | Pointe Creatine Kinase Reagent | HORIBA INSTRUMENTS INCORPORATED | 2021-01-30 |
| 03610230006948 | Yumizen C1200 CK-NAC | HORIBA ABX SAS | 2020-08-31 |
| 00811727015785 | Pointe Creatine Kinase for BS480 | HORIBA INSTRUMENTS INCORPORATED | 2020-05-28 |
| 00380740161705 | ARCHITECT | Abbott GmbH | 2020-01-25 |
| 00380740161699 | ARCHITECT | Abbott GmbH | 2020-01-25 |
| 00380740132590 | Alinity | Abbott GmbH | 2019-05-07 |
| 00386100002183 | CK Reagent Kit | MEDICA CORPORATION | 2019-02-14 |
| 15099590020262 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 15099590010744 | AU | Beckman Coulter, Inc. | 2016-09-24 |
| 00015482771188 | SPOTCHEM™ II Inorganic Phosphorous | ARKRAY USA, INC. | 2016-09-23 |
| 00015482771027 | SPOTCHEM™ II Uric Acid | ARKRAY USA, INC. | 2016-09-23 |
| 00015482771126 | SPOTCHEM™ II CPK | ARKRAY USA, INC. | 2016-09-23 |
| 04015630912889 | Creatine Kinase liquid, acc. to IFCC | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630921324 | Creatine Kinase liquid, acc. to IFCC | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630921331 | Creatine Kinase liquid, acc. to IFCC | Roche Diagnostics GmbH | 2016-09-20 |
| 05055273201420 | CK-MB | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 05055273201413 | CK-MB CONTROL | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 05055273201390 | CK NAC | RANDOX LABORATORIES LIMITED | 2016-09-16 |
| 05055273201406 | CK NAC | RANDOX LABORATORIES LIMITED | 2016-09-09 |
| 15099590575212 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590575199 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 15099590575106 | Synchron | Beckman Coulter, Inc. | 2016-08-24 |
| 03610230004951 | ABX PENTRA CK NAC CP | HORIBA ABX SAS | 2016-08-23 |