510(k) K980798 ยท LYR Helicobacter Pylori
BIOSIGN H. PYLORI WB-NEW ONE-STEP ANTI-H. PYLORI ANTIBODY TEST
| Applicant | Princeton BioMeditech Corp., Monmouth Junction NJ, US |
| Decision | Substantially Equivalent, Sep 22, 1998 |
| Received | Mar 2, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980798
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jan 10, 2024 | Immunostics, Inc. Detector H. Pylori, Catalog Number IHP-30 Open, Classified |
LYR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.