510(k) K984544 ยท LYR Helicobacter Pylori
THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S
| Applicant | Enteric Products, Inc., Stony Brook NY, US |
| Decision | Substantially Equivalent, Feb 18, 1999 |
| Received | Dec 22, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K984544
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.