K862301 is an FDA 510(k) clearance for the IL SYSTEM 810, ACL AND THE REAGENT SETS. This device is classified as a Test, Thrombin Time (Class II - Special Controls, product code GJA).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on September 3, 1986, 78 days after receiving the submission on June 17, 1986.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.7875.
| 510(k) Number | K862301 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 17, 1986 |
| Decision Date | September 03, 1986 |
| Days to Decision | 78 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | GJA — Test, Thrombin Time |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.7875 |