K063679 is an FDA 510(k) clearance for the ACL TOP. This device is classified as a Instrument, Coagulation, Automated (Class II - Special Controls, product code GKP).
Submitted by Instrumentation Laboratory CO (Bedford, US). The FDA issued a Cleared decision on January 12, 2007, 32 days after receiving the submission on December 11, 2006.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5400.
| 510(k) Number | K063679 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 11, 2006 |
| Decision Date | January 12, 2007 |
| Days to Decision | 32 days |
| Submission Type | Special |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | GKP — Instrument, Coagulation, Automated |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5400 |