510(k) K052662 ยท CGJ Radioimmunoassay, Follicle-Stimulating Hormone
ONE STEP FSH MENOPAUSAL TEST
| Applicant | Ind Diagnostic, Inc., Delta, B.C., CA |
| Decision | Substantially Equivalent, Nov 30, 2005 |
| Received | Sep 27, 2005 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K052662
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 23, 2023 | Universal Meditech Inc. DiagnosUS One Step FSH Menopausal Test (Strip) REF 210-07 Open, Classified |
CGJ | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.