510(k) K043143 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
SAFEPICO
| Applicant | Radiometer Medical Aps, Bronshoj, DK |
| Decision | Substantially Equivalent, Apr 22, 2005 |
| Received | Nov 15, 2004 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K043143
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Aug 29, 2006 | Radiometer America Inc SafePICO Samplers, self-filling arterial blood samplers. The syringe blood samplers are individually packed in plastic pouches and distributed in cartons. Each carton contains ten (10) boxes and eac Terminated |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.