510(k) K936013 ยท LCX Kit, Test, Pregnancy, Hcg, Over The Counter
EVATEST STRIP
| Applicant | Boehringer Mannheim Italia Spa, I-20126 Milano, Italy, IT |
| Decision | Substantially Equivalent, Feb 25, 1994 |
| Received | Dec 16, 1993 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K936013
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.