510(k) K003794 ยท LYR Helicobacter Pylori
ELISA TEST, SEROLOGY
| Applicant | Micro Detect, Inc., Tustin CA, US |
| Decision | Substantially Equivalent, Mar 30, 2001 |
| Received | Dec 8, 2000 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K003794
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.