The following data is part of a premarket notification filed by Accumetrics, Inc. with the FDA for Ultegra System Analyzer, Ultegra System Rpfa-trap Test Cartidges, Ultegra System Rpfa-trap Level One Qc, Ultegra System.
| Device ID | K992531 |
| 510k Number | K992531 |
| Device Name: | ULTEGRA SYSTEM ANALYZER, ULTEGRA SYSTEM RPFA-TRAP TEST CARTIDGES, ULTEGRA SYSTEM RPFA-TRAP LEVEL ONE QC, ULTEGRA SYSTEM |
| Classification | System, Automated Platelet Aggregation |
| Applicant | ACCUMETRICS, INC. 3985 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Frances E Harrison |
| Correspondent | Frances E Harrison ACCUMETRICS, INC. 3985 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-07-28 |
| Decision Date | 1999-12-20 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234500095 | K992531 | 000 |
| 10711234150108 | K992531 | 000 |
| 10711234150115 | K992531 | 000 |
| 10711234150122 | K992531 | 000 |
| 10711234500040 | K992531 | 000 |
| 10711234500118 | K992531 | 000 |
| 10711234500132 | K992531 | 000 |
| 10711234500149 | K992531 | 000 |
| 10711234500156 | K992531 | 000 |
| 10711234500163 | K992531 | 000 |
| 10711234500170 | K992531 | 000 |
| 10711234150092 | K992531 | 000 |