The following data is part of a premarket notification filed by Accumetrics, Inc. with the FDA for Verifynow-p2y12 Assay.
| Device ID | K051231 |
| 510k Number | K051231 |
| Device Name: | VERIFYNOW-P2Y12 ASSAY |
| Classification | System, Automated Platelet Aggregation |
| Applicant | ACCUMETRICS, INC. 3985 SORRENTO VALLEY BLVD. San Diego, CA 92121 |
| Contact | Barbara Stevens |
| Correspondent | Barbara Stevens 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 | 2005-05-13 |
| Decision Date | 2005-08-05 |
| Summary: | summary |