510(k) K993547 ยท CFN Method, Nephelometric, Immunoglobulins (G, A, M)
BECKMAN COULTER IMMAGE IMMUNOCHEMISTRY SYSTEM LOW CONCENTRATION IMMUNOGLOBULIN M (IGMLC) REAGENT, BECKMAN COULTER CEREB
| Applicant | Beckman Coulter, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Feb 1, 2000 |
| Received | Oct 19, 1999 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K993547
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 23, 2004 | Beckman Coulter Inc IMMAGE IGALC Reagent
Part Number: 447460 Terminated |
CFN | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.