Product code JHS
- Device name
- Differential Rate Kinetic Method, 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 |
|---|---|---|---|
| K160570 | Creatine Kinase | Roche Diagnostics Operations (Rdo) | 2016-05-25 |
| K102706 | CKMB UDR ASSAY | SENTINEL CH. SpA | 2011-08-19 |
| K082226 | S40 CREATINE KINASE (CK) | Alfa Wassermann Diagnostic Technologies, Inc. | 2008-09-18 |
| K062128 | THE DIMENSION VISTA FLEX REAGENT CARTRIDGES / KIT ASSAYS | Dade Behring, Inc. | 2006-08-21 |
| K990439 | CARESIDE CK | Careside, Inc. | 1999-04-19 |
| K990434 | CARESIDE CKMB | Careside, Inc. | 1999-04-19 |
| K981495 | IMMULITE CK-MB, CATALOG # LKCP1 (100 TESTS), LKCP5 (500 TESTS) | Diagnostic Products Corp. | 1998-06-10 |
| K962126 | ACS CKMB II IMMUNOASSAY | Ciba Corning Diagnostics Corp. | 1996-06-21 |
| K952250 | STRATUS CK-MB DENDRIMER FLUOROMETRIC ENZYME IMMUNOASSAY & STRATUS CK-MB DENDRIMER HIGH SAMPLE DILUENT | Dade Intl., Inc. | 1995-07-17 |
| K945083 | ACCESS CK-MB REAGENTS | Bio-Rad Laboratories, Inc. | 1994-11-21 |
| K943024 | KINASE ISOENZYME | Dupont Medical Products | 1994-08-02 |
| K941584 | CREATINE KINASE METHOD | Dupont Medical Products | 1994-07-06 |
| K903025 | ROCHE ISOMUNE- CK | Roche Diagnostic Systems, Inc. | 1990-08-09 |
| K900806 | STRATUS(R) CK-MB FLUOROMETRIC ENZYME IMMUNOASSAY | Baxter Healthcare Corp | 1990-03-23 |
| K883223 | CHECK-MM | Intl. Immunoassay Laboratories, Inc. | 1988-09-30 |
| K872029 | UNI-FAST CREATINE KINASE TEST (CK) | Sclavo, Inc. | 1987-06-17 |
| K861387 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDES (CK-MB) | Eastman Kodak Company | 1986-06-27 |
| K855188 | CPK (UV) REAGENT KIT | Technostics Intl. | 1986-03-05 |
| K854708 | DART CK-MB REAGENT SYSTEM | Coulter Electronics, Inc. | 1985-12-30 |
| K843007 | CARDI-CK EIA TEST KIT CK-MB ISOENZYME | Intl. Immunoassay Laboratories, Inc. | 1984-09-07 |
| K823211 | CK-UV REAGENT | Biorent Diagnostic, Inc. | 1982-11-22 |
| K820722 | KODAK EKTACHEM CLINICAL CHEMISTRY SLIDDE | Eastman Kodak Company | 1982-04-01 |
| K813406 | CPK(CK) IN VITRO DIAG. REAGENT SET | Pointe Scientific, Inc., | 1981-12-22 |
| K810997 | WORTHINGTON CK (NAC) REAGENT SET | Worthington Diagnostic Systems | 1981-04-23 |
| K803169 | CARDIOZYME PLUS CK-TOTAL #65046 | Harleco | 1981-01-09 |
| K802521 | CK-MB(IMMUNOLOGICAL) | Biodynamics Corp. | 1980-11-12 |
| K801668 | QUICK CEPT | Laboratory Diagnostics Co., Inc. | 1980-08-13 |
| K800028 | WORTHINGTON FLOZYME* CPK (340NM) | Worthington Diagnostic Systems | 1980-01-21 |
| K792023 | ESKACHEM, CK-MB REAGENT | Smithkline Diagnostics, Inc. | 1979-10-30 |
| K790917 | SPIN CHEM CK-NAC REAGENT | Smithkline Diagnostics, Inc. | 1979-06-22 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 00630414293592 | Atellica IM CKMB | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 00630414294148 | Atellica IM CKMB | Siemens Healthcare Diagnostics Inc. | 2020-05-31 |
| 10758750005154 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2020-04-18 |
| 10758750005123 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2020-04-18 |
| 07613336121122 | Creatine Kinase | Roche Diagnostics GmbH | 2020-03-05 |
| 00630414598604 | Atellica IM CKMB DIL | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 00630414598598 | Atellica IM CKMB Calibrator | Siemens Healthcare Diagnostics Inc. | 2018-02-06 |
| 00630414598581 | Atellica IM CKMB | Siemens Healthcare Diagnostics Inc. | 2017-12-27 |
| 00630414598574 | Atellica IM CKMB | Siemens Healthcare Diagnostics Inc. | 2017-12-22 |
| 04015630940813 | Creatine Kinase | Roche Diagnostics GmbH | 2016-12-12 |
| 00842768025525 | Dimension® Flex® reagent cartridge CKI | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414177441 | ADVIA Centaur® CKMB | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414177434 | ADVIA Centaur® CKMB | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414175324 | ADVIA Centaur® CKMB Diluent | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00630414124803 | ADVIA Centaur® Systems, ACS:180® Systems CKMB Calibrator | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 00842768027918 | Dimension Vista® Flex® reagent cartridge MBI | Siemens Healthcare Diagnostics Inc. | 2016-09-24 |
| 04015630940806 | Creatine Kinase | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630926909 | Creatine kinase | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630926831 | Creatine KinaseMB | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630921058 | Creatine KinaseMB | Roche Diagnostics GmbH | 2016-09-20 |
| 04015630921041 | CKL Creatine Kinase | Roche Diagnostics GmbH | 2016-09-20 |
| 08058056680297 | CKMB UDR | SENTINEL CH. SPA | 2016-09-16 |
| 10758750004201 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |
| 10758750004294 | VITROS | ORTHO-CLINICAL DIAGNOSTICS, INC. | 2016-08-23 |