510(k) K971209 ยท JHI Visual, Pregnancy Hcg, Prescription Use
CLINITEK HCG TEST STRIPS
| Applicant | Bayer Corp., Elkhart IN, US |
| Decision | Substantially Equivalent, Apr 4, 1997 |
| Received | Apr 2, 1997 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K971209
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.