510(k) K940549 ยท CEP Radioimmunoassay, Luteinizing Hormone
ACCESS(R) HUMAN LUTEINZING HORMONE ASSAY
| Applicant | Bio-Rad Laboratories, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Apr 6, 1994 |
| Received | Feb 7, 1994 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K940549
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Dec 20, 2012 | Beckman Coulter Inc. The Access hLH assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of luteinizing hormone (LH) levels in human serum and plasma using the Access Immunoass Terminated |
CEP | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.