ACL TOP
FDA 510(k) clearance K063679 · decided 2007-01-12
Clearance details
- K-number
- K063679
- Device name
- ACL TOP
- Applicant
- Instrumentation Laboratory CO
- Decision
- Substantially Equivalent
- Date received
- 2006-12-11
- Decision date
- 2007-01-12
- Days to decision
- 32 days
- Clearance type
- Special
- 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
+ Add to Predicate Builder ◉ Watch Instrumentation Laboratory CO
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| Instrumentation Laboratory ACL TOP Coagulation Analyzer (Base Model only). Blood analyzer. recall (Z-1127-2007) | Instrumentation Laboratory Co. | 2007-08-07 |