510(k) K040958 ยท JJE Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
PRESTIGE MODELS 24I AND 400 AND MGC MODEL 240
| Applicant | Tokyo Boeki Medical System , Ltd., Raleigh NC, US |
| Decision | Substantially Equivalent, Feb 15, 2005 |
| Received | Apr 13, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K040958
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.