ACL ELITE; ACL ELITE PRO
FDA 510(k) clearance K060162 · decided 2006-02-21
Clearance details
- K-number
- K060162
- Device name
- ACL ELITE; ACL ELITE PRO
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2006-01-23
- Decision date
- 2006-02-21
- Days to decision
- 29 days
- Clearance type
- Special
- Product code
- JPA
- Device class
- 2
- Regulation number
- 864.5425
- 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 8000 Coagulation Analyzer, PN 00000880011 Coagulation testing. recall (Z-0803-2011) | Instrumentation Laboratory Co. | 2010-12-27 |
| ACL 9000 Coagulation Analyzer, PN 00000990011 Coagulation testing. recall (Z-0804-2011) | Instrumentation Laboratory Co. | 2010-12-27 |
| ACL 10000 Coagulation Analyzer, PN 0000100011 Coagulation testing. recall (Z-0805-2011) | Instrumentation Laboratory Co. | 2010-12-27 |
| ACL ELITE Coagulation Analyzer, PN 00000880311 Coagulation testing. recall (Z-0806-2011) | Instrumentation Laboratory Co. | 2010-12-27 |
| ACL ELITE PRO Coagulation Analyzer, PN 00001000311 Coagulation testing. recall (Z-0807-2011) | Instrumentation Laboratory Co. | 2010-12-27 |