HemosIL D-Dimer HS
FDA 510(k) clearance K151534 · decided 2015-07-06
Clearance details
- K-number
- K151534
- Device name
- HemosIL D-Dimer HS
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2015-06-08
- Decision date
- 2015-07-06
- Days to decision
- 28 days
- Clearance type
- Special
- Product code
- DAP
- Device class
- 2
- Regulation number
- 864.7320
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| HemosIL D-Dimer HS 500 (K172903) | Instrumentation Laboratory CO | 2017-11-22 |
| STA® - Liatest® D-Di (K162227) | Diagnostica Stago | 2016-12-10 |
| HemosIL D-Dimer HS (K160885) | Instrumentation Laboratory CO | 2016-10-27 |
| STA LIATEST D-DI (K141144) | Diagnostica Stago | 2014-09-03 |
| VIDAS D-DIMER EXCLUSION II (DEX2) (K112818) | bioMerieux, Inc. | 2012-07-31 |
| STRATUS CS ACUTE CARE D-DIMER (K110303) | Siemens Healthcare Diagnostics | 2011-05-16 |
| INNOVANCE D-DIMER, MODEL OPBP09 (K093626) | Siemens Healthcare Diagnostics | 2010-11-29 |
| HEMOSIL D-DIMER HS 500, CONTROLS (K090264) | Instrumentation Laboratory CO | 2010-02-05 |
| INNOVANCE D-DIMER, MODEL OPBP09 (K091916) | Siemens Healthcare Diagnostics | 2009-10-29 |
| INNOVANCE D-DIMER AND INNOVANCE D-DIMER CONTROLS (K081732) | Siemens Healthcare Diagnostics | 2008-10-24 |
| HEMOSIL D-DIMER (K073042) | Instrumentation Laboratory | 2008-07-31 |
| DIMERTEST (K080069) | American Diagnostica, Inc. | 2008-02-13 |
Recalls involving this device
No recalls on record reference this clearance.