510(k) K050741 ยท JHI Visual, Pregnancy Hcg, Prescription Use
IND ONE STEP HCG PREGNANCY TEST - CASSETTE FORMAT
| Applicant | Ind Diagnostic, Inc., Delta, B.C., CA |
| Decision | Substantially Equivalent, May 16, 2005 |
| Received | Mar 21, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K050741
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2023 | Universal Meditech Inc. DeTec hCG Pregnancy Urine Test Cassette Format, REG Cat: 100-13 Open, Classified |
JHI | None listed |
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS hCG Pregnancy Urine Test Cassette Format REF 100-13 Open, Classified |
JHI | None listed |
| Jan 26, 2009 | Stryker Howmedica Osteonics Corp. Accolade HFx
These devices are modular components of a total hip system. These femoral stems are intended for use with femoral heads and acetabular components in primary or revision total hip arthro Terminated |
LZO | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.