510(k) K083465
- Device
- DIMENSION VISTA CREATINE KINASE FLEX REAGENT CARTRIDGE AND DIMENSION VISTA CREATINE KINASE MB FLEX REAGENT CARTRIDGE
- Applicant
- SIEMENS HEALTHCARE DIAGNOSTICS
- 510(k) number
- K083465
- Product code
- CGS
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2009-02-27
- Date received
- 2008-11-24
- Regulation
- 862.1215
- Classification name
- Nad Reduction/nadh Oxidation, Cpk Or Isoenzymes
- Medical specialty
- Clinical Chemistry
- Review panel
- Clinical Chemistry
- Device class
- 2
- Clearance type
- Special
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- VICTOR M CARRIO
- Address
- Ms 514, P.O. Box 6101 Newark DE US 19714 19714
FDA Registration Numbers#
- 3013660430
- 8020316
- 3006198300
- 2030861
- 1181121
- 2050012
- 9680746
- 3005333358
- 2432235
- 8023024
- 1832216
- 8040374
- 1000403749
- 2517506
- 2247288
- 1827821
- 3004493545
- 3016438761
- 3003593973
- 2050010
- 3010825766
- 2085064
- 1616487
- 1220972
- 3000148879
Source Documents#
Other 510(k) Records For Product Code CGS #
| 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 |
| 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 |
Legacy Summary#
summary
FDA Review#
Decision Summary