510(k) K023480 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ACCESS TOTAL BHCG
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Dec 20, 2002 |
| Received | Oct 17, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K023480
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2011 | Beckman Coulter Inc. Access Immunoassay Systems Total hCG.
The Access Total hCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total hCG levels in human serum and pla Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.