The following data is part of a premarket notification filed by Aggredyne, Inc. with the FDA for Aggreguide A-100 Adp.
| Device ID | K181777 |
| 510k Number | K181777 |
| Device Name: | AggreGuide A-100 ADP |
| Classification | System, Automated Platelet Aggregation |
| Applicant | Aggredyne, Inc. 10530 Rockely Road, Suite 150 Houston, TX 77099 |
| Contact | Phillip Speros |
| Correspondent | Phillip Speros Aggredyne, Inc. 10530 Rockely Road, Suite 150 Houston, TX 77099 |
| Product Code | JOZ |
| CFR Regulation Number | 864.5700 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-07-03 |
| Decision Date | 2019-03-29 |