510(k) K021229 ยท DDR Myoglobin, Antigen, Antiserum, Control
MYOGLOBIN AND MYOGLOBIN CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 973243, 973244
| Applicant | Beckman Coulter, Inc., Chaska MN, US |
| Decision | Substantially Equivalent, Jun 28, 2002 |
| Received | Apr 18, 2002 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K021229
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| May 22, 2009 | Beckman Coulter Inc Access Myoglobin Reagents Kits, Part Number: 973243.
The Access Myoglobin assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of Myoglobin levels in huma Terminated |
DDR | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.