The following data is part of a premarket notification filed by Aggredyne, Inc. with the FDA for Aggreguide A-100 Aa Assay, Aggreguide A-100 Instrument.
| Device ID | K163274 |
| 510k Number | K163274 |
| Device Name: | AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument |
| Classification | System, Automated Platelet Aggregation |
| Applicant | Aggredyne, Inc. 10530 Rockley Road, Suite 150 Houston, TX 77099 |
| Contact | Philip C. Speros |
| Correspondent | Philip C. Speros Aggredyne, Inc. 10530 Rockley Road, Suite 150 Houston, TX 77099 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-11-21 |
| Decision Date | 2017-04-05 |
| Summary: | summary |