THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
FDA 510(k) clearance K002177 · decided 2000-09-14
Clearance details
- K-number
- K002177
- Device name
- THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
- Applicant
- Haemoscope Corp.
- Decision
- Substantially Equivalent
- Date received
- 2000-07-19
- Decision date
- 2000-09-14
- Days to decision
- 57 days
- Clearance type
- Traditional
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Skokie, IL, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Haemonetics TEG Hemostasis System Level II Control, Catalog number: 8002. Level II Control recall (Z-1130-2015) | Haemonetics Corporation | 2015-02-19 |
| TEG 5000 Thromboelastograph Coagulation Analyzer Product Usage: Multipurpose System for In recall (Z-1796-2013) | Haemonetics Corporation | 2013-07-24 |
| TEG Hemostasis System Level II Control: Biological Quality Control Level II Kit for Thromb recall (Z-2742-2011) | Haemoscope Division of Haemonetics Corp | 2011-07-06 |
| TEG 5000 Thrombelastograph Hemostasis Analyzer System; a multipurpose system for in vitro recall (Z-1738-2011) | Haemoscope Division of Haemonetics Corp | 2011-03-21 |