ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
FDA 510(k) clearance K150877 · decided 2015-12-13
Clearance details
- K-number
- K150877
- Device name
- ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS; ACL TOP 550 CTS; ACL TOP 750; ACL TOP 750 CTS; ACL TOP 750 LAS
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2015-04-01
- Decision date
- 2015-12-13
- Days to decision
- 256 days
- Clearance type
- Traditional
- 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 TOP Family 50 Series Models as follows: In vitro diagnostic clinical use in the hemost recall (Z-2578-2023) | Instrumentation Laboratory | 2023-09-12 |