510(k) K980173 ยท JHI Visual, Pregnancy Hcg, Prescription Use
ACCESS TOTAL BHCG REAGENTS ON THE ACCESS IMMUNOASSAY ANALYZER; 33500, 33505
| Applicant | Beckman Instruments, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Mar 18, 1998 |
| Received | Jan 20, 1998 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K980173
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Mar 21, 2011 | Beckman Coulter Inc. Access Total BhCG (BhCG) Assay Part Number 33500
The Access Total BhCG assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of total BhCG levels in human s Terminated |
JHI | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.