510(k) K163274 ยท JOZ System, Automated Platelet Aggregation
AggreGuide A-100 AA Assay, AggreGuide A-100 Instrument
| Applicant | Aggredyne, Inc., Houston TX, US |
| Decision | Substantially Equivalent, Apr 5, 2017 |
| Received | Nov 21, 2016 |
| Type | Special |
| FDA record | Open on fda.gov |
Recalls that name K163274
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2019 | Aggredyne, Inc. AggreGuide A-100 Instrument Completed |
JOZ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.