STA® - Liatest® D-Di
FDA 510(k) clearance K162227 · decided 2016-12-10
Clearance details
- K-number
- K162227
- Device name
- STA® - Liatest® D-Di
- Applicant
- Diagnostica Stago
- Decision
- Substantially Equivalent
- Date received
- 2016-08-08
- Decision date
- 2016-12-10
- Days to decision
- 124 days
- Clearance type
- Traditional
- Product code
- DAP
- Device class
- 2
- Regulation number
- 864.7320
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Asnieres Sur Seine, FR
- Third-party review
- No
- Expedited review
- No
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| Record | Firm | Date |
|---|---|---|
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| INNOVANCE D-DIMER, MODEL OPBP09 (K093626) | Siemens Healthcare Diagnostics | 2010-11-29 |
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| 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
| Record | Firm | Date |
|---|---|---|
| Brand Name: STA Liatest D-Di Product Name: STA Liatest D-Di Model/Catalog Number: REF 0051 recall (Z-1585-2026) | Diagnostica Stago, Inc. | 2026-03-19 |
| Product: STA Liatest D-Di; REF: 00515; recall (Z-0205-2026) | Diagnostica Stago, Inc. | 2025-10-16 |