Dimension Vista MMB Assay
FDA 510(k) clearance K143720 · decided 2015-09-18
Clearance details
- K-number
- K143720
- Device name
- Dimension Vista MMB Assay
- Applicant
- Siemens Healthcare Diagnostics
- Decision
- Substantially Equivalent
- Date received
- 2014-12-29
- Decision date
- 2015-09-18
- Days to decision
- 263 days
- Clearance type
- Traditional
- Product code
- JHY
- Device class
- 2
- Regulation number
- 862.1215
- Medical specialty
- Clinical Chemistry
- Advisory committee
- Clinical Chemistry
- Location
- Newark, DE, US
- Third-party review
- No
- Expedited review
- No
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| EASYRA CK-MB REAGENT, EASYRA CRP REAGENT, EASY CAL CRP CALIBRATOR KIT, EASYQC CRP QUALITY CONTROL MATERIAL (K130080) | Medica Corporation | 2014-05-13 |
| ELECSYS CK-MB STAT IMMUNOASSAY (K140404) | Roche Diagnostics | 2014-05-08 |
| ELECSYS CK-MB STAT IMMUNOASSAY, ELECSYS CK-MB IMMUNOASSAY (K132571) | Roche Diagnostics | 2013-10-18 |
| OLYMPUS CK-MB REAGENT (K070835) | Olympus Life & Material Science Europa GmbH (Irish | 2007-06-04 |
| SPIFE CK KIT, MODEL 3332, 3333 (K022757) | Helena Laboratories | 2002-10-11 |
| MODIFICATION TO ELECSYS CK-MB STAT, ELECSYS CK-MB (K022654) | Roche Diagnostics Corp. | 2002-08-29 |
| ELECSYS CK-MB STAT (K974421) | Boehringer Mannheim Corp. | 1997-12-17 |
| MMB METHOD (K970343) | Dade Chemistry Systems, Inc. | 1997-02-14 |
| CK-MB METHOD FOR THE TECHNICON IMMUNO 1 SYSTEM IN-VITRO (K961412) | Bayer Corp. | 1996-06-18 |
| AURAFLEX CK-MB 200TEST PACK, CALIBRATOR PACK (K951638) | Organon Teknika Corp. | 1995-05-02 |
| IMX(R) STAT CK-MB (K931172) | Abbott Laboratories | 1993-06-15 |
| OPUS(R) CK-MB (K924429) | Pb Diagnostic Systems, Inc. | 1992-10-15 |
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Dimension Vista Mass Creatine Kinase (MMB) Flex reagent cartridge recall (Z-1672-2018) | Siemens Healthcare Diagnostics, Inc. | 2018-05-04 |
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