510(k) K041502 ยท JOZ System, Automated Platelet Aggregation
THROMBELASTOGRAPH (TEG) PLATELET MAPPING ASSAY
| Applicant | Haemoscope Corp., Niles IL, US |
| Decision | Substantially Equivalent, Sep 1, 2004 |
| Received | Jun 7, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K041502
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 19, 2022 | Haemonetics Corporation Product Name: TEG5000 Analyzer (07-022, 07-033) with TEG Analytical Software (07-030, 07-031) and TEG Platelet Mapping Assay -
PlateletMapping ADP & AA (07-014),
PlateletMapping ADP (07-015),
Platelet Terminated |
JPA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.