K992531 is an FDA 510(k) clearance for the ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM. This device is classified as a System, Automated Platelet Aggregation (Class II - Special Controls, product code JOZ).
Submitted by Accumetrics, Inc. (San Diego, US). The FDA issued a Cleared decision on December 20, 1999, 145 days after receiving the submission on July 28, 1999.
This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.5700.
| 510(k) Number | K992531 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | July 28, 1999 |
| Decision Date | December 20, 1999 |
| Days to Decision | 145 days |
| Submission Type | Traditional |
| Review Panel | Hematology (HE) |
| Summary | Summary PDF |
| Product Code | JOZ — System, Automated Platelet Aggregation |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 864.5700 |