510(k) K853239 ยท KFF Assay, Heparin
HEPTEST-A QUANTITATIVE HEPARIN IN PLASMA ASSAY
| Applicant | Haemachem, Inc., St. Louis MO, US |
| Decision | Substantially Equivalent, Nov 5, 1985 |
| Received | Aug 1, 1985 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K853239
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.