K881367 is an FDA 510(k) clearance for the ACL SYSTEMS 100, 200, 300 AND 300+ COAGULATION SYS. This device is classified as a System, Multipurpose For In Vitro Coagulation Studies (Class II - Special Controls, product code JPA).
Submitted by Instrumentation Laboratory CO (Lexington, US). The FDA issued a Cleared decision on June 27, 1988, 88 days after receiving the submission on March 31, 1988.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K881367 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 31, 1988 |
| Decision Date | June 27, 1988 |
| Days to Decision | 88 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | — |
| Product Code | JPA — System, Multipurpose For In Vitro Coagulation Studies |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |