The following data is part of a premarket notification filed by Accumetrics, Inc. with the FDA for Verifynow-aspirin Assay.
| Device ID | K042423 |
| 510k Number | K042423 |
| Device Name: | VERIFYNOW-ASPIRIN 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-07 |
| Decision Date | 2004-10-06 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10711234150023 | K042423 | 000 |
| 10711234150016 | K042423 | 000 |