K150877 is an FDA 510(k) clearance for the ACL TOP FAMILY 50 SERIES: ACL TOP 350 CTS. 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 December 13, 2015, 256 days after receiving the submission on April 1, 2015.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5400.
| 510(k) Number | K150877 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | April 01, 2015 |
| Decision Date | December 13, 2015 |
| Days to Decision | 256 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 |