510(k) K020799 ยท JHI Visual, Pregnancy Hcg, Prescription Use
QUICKVUE ONE-STEP HCG-URINE
| Applicant | Quidel Corp., San Diego CA, US |
| Decision | Substantially Equivalent, May 17, 2002 |
| Received | Mar 12, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K020799
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 1, 2011 | Quidel Corporation QuickVue One-Step hCG Urine, Quidel Catalog Number: 20109, Lot Number: 706842 Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.