510(k) K972209 ยท KFF Assay, Heparin
SPECTROLYSE HEPARIN (ANTI-IIA)
| Applicant | Medical Diagnostic Technologies, Inc., Ventura CA, US |
| Decision | Substantially Equivalent, Aug 12, 1997 |
| Received | Jun 11, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K972209
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.