510(k) K003767 ยท LCO Platelet Factor 4 Radioimmunoassay
ASSERACHROM HPIA TEST KIT
| Applicant | Diagnostica Stago, Inc., Parsippany NJ, US |
| Decision | Substantially Equivalent, Feb 12, 2001 |
| Received | Dec 6, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003767
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 14, 2026 | Diagnostica Stago, Inc. Asserachrom HPIA.
Model/Catalog Number: 00615.
The Asserachrom HPIA kit is intended for the qualitative detection in plasma or serum of the anti-heparin-platelet factor 4 (PF4) antibodies generated Open, Classified |
LCO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.