K073377 is an FDA 510(k) clearance for the ACL TOP (WITH SYSTEM SOFTWARE V3.0.0). 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 May 4, 2008, 153 days after receiving the submission on December 3, 2007.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5400.
| 510(k) Number | K073377 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 03, 2007 |
| Decision Date | May 04, 2008 |
| Days to Decision | 153 days |
| Submission Type | Traditional |
| 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 |