510(k) K963868 ยท DEW Igg, Antigen, Antiserum, Control
IMMAGE IMMUNOCHEMISTRY SYSTEM IMMUNOGLOBULIN G (IGG), A (IGA) AND M (IGM)
| Applicant | Beckman Instruments, Inc., Brea CA, US |
| Decision | Substantially Equivalent, Feb 10, 1997 |
| Received | Sep 26, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K963868
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 17, 2024 | Beckman Coulter Inc. IMMAGE Immunochemistry Systems IGM Immunoglobulin M Reagent REF 447610
IGM reagent, when used in conjunction with IMMAGE Immunochemistry Systems and Calibrator 1, is intended for the quantitative det Open, Classified |
DEW | None listed |
| Jul 23, 2004 | Beckman Coulter Inc IMMAGE IgM Reagent
Part No.: 447610 Terminated |
DEW | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.