510(k) K052694 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ONE STEP HCG PREGNANCY TEST - 2000 MIU/ML, MODEL 100 SERIES.
| Applicant | Ind Diagnostic, Inc., Delta, B.C., CA |
| Decision | Substantially Equivalent, Dec 16, 2005 |
| Received | Sep 28, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052694
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.