HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
FDA 510(k) clearance K090209 · decided 2009-06-02
Clearance details
- K-number
- K090209
- Device name
- HEMOSIL LIQUID HEPARIN, HEPARIN CALIBRATORS AND LMW AND UF HEPARIN CONTROLS
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2009-01-28
- Decision date
- 2009-06-02
- Days to decision
- 125 days
- Clearance type
- Traditional
- Product code
- KFF
- Device class
- 2
- Regulation number
- 864.7525
- Medical specialty
- Hematology
- Advisory committee
- Hematology
- Location
- Bedford, MA, US
- Third-party review
- No
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| ACL ELITE- Analyzer designed specifically for clinical use in the hemostasis laboratory, f recall (Z-1304-2023) | Instrumentation Laboratory | 2024-09-30 |
| ACL ELITE PRO-Analyzer designed specifically for clinical use in the hemostasis laboratory recall (Z-1305-2023) | Instrumentation Laboratory | 2024-09-30 |
| ACL ELITE Refurbished-Analyzer designed specifically for clinical use in the hemostasis la recall (Z-1306-2023) | Instrumentation Laboratory | 2024-09-30 |
| ACL ELITE PRO Refurbished)-Analyzer designed specifically for clinical use in the hemostas recall (Z-1307-2023) | Instrumentation Laboratory | 2024-09-30 |