510(k) K983255 ยท LYR Helicobacter Pylori
MODIFICATION TO: PREMIER PLATINUM HPSA
| Applicant | Meridian Diagnostics, Inc., Cincinnati OH, US |
| Decision | Substantially Equivalent, Dec 17, 1998 |
| Received | Sep 15, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K983255
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 23, 2003 | Meridian Bioscience Inc Premier Platinum brand HpSA, diagnostic test kits, one kit per pouch, one pouch per shipping box. Terminated |
LYR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.