K912087 is an FDA 510(k) clearance for the ACL COAGULATION SYSTEMS,MODELS 1000,2000,3000,PLUS. 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 September 19, 1991, 129 days after receiving the submission on May 13, 1991.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5425.
| 510(k) Number | K912087 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | May 13, 1991 |
| Decision Date | September 19, 1991 |
| Days to Decision | 129 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Statement |
| Product Code | JPA — System, Multipurpose For In Vitro Coagulation Studies |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5425 |