ACL TOP MODEL, TOP
FDA 510(k) clearance K033414 · decided 2004-01-12
Clearance details
- K-number
- K033414
- Device name
- ACL TOP MODEL, TOP
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2003-10-27
- Decision date
- 2004-01-12
- Days to decision
- 77 days
- Clearance type
- Abbreviated
- Product code
- GKP
- Device class
- 2
- Regulation number
- 864.5400
- 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 Futura, ACL Advance and ACL TOP Coagulation Analyzers used with the HemosIL RecombiPla recall (Z-0915-05) | Instrumentation Laboratory Co. | 2005-06-21 |