510(k) K962158 ยท JKA Tubes, Vials, Systems, Serum Separators, Blood Collection
PICO MODELS 30, 50, 70
| Applicant | Radiometer America, Inc., Westlake OH, US |
| Decision | Substantially Equivalent, Oct 29, 1996 |
| Received | Jun 4, 1996 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K962158
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Apr 8, 2022 | Radiometer Medical ApS Radiometer, REF:956-552, PIC050- Arterial Blood Sampler 1 X 2 mL, 80 IU electrolyte-balanced heparin. Not for injection. , IVD, Rx Only, Sterile EO, CE Open, Classified |
JKA | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.