510(k) K200403 ยท JGS Electrode, Ion Specific, Sodium
Stat Profile Prime Plus Analyzer System
| Applicant | Nova Biomedical Corporation, Walham MA, US |
| Decision | Substantially Equivalent, Apr 14, 2020 |
| Received | Feb 19, 2020 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K200403
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 1, 2023 | Nova Biomedical Corporation Nova Biomedical Prime Plus Analyzer -Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.
(1) PN 57400 Stat Profile Prime Plus Analyzer
(2) PN 59508 Stat Pro Open, Classified |
JGS | None listed |
| Nov 1, 2023 | Nova Biomedical Corporation Nova Stat Profile Prime Plus POC Analyzer (CE)-Intended to measure certain gases in blood, serum, plasma or pH of blood, serum, and plasma.
(1) PN 63368 Stat Profile Prime Plus POC Analyzer
(2) PN 63 Open, Classified |
JGS | None listed |
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.