Stat Profile Prime Plus Analyzer System— 510(k) K200403
Substantially EquivalentNova Biomedical Corporation
FDA 510(k) clearance K200403 for Stat Profile Prime Plus Analyzer System, Substantially Equivalent on 2020-04-14. Applicant: Nova Biomedical Corporation. Device class: 2.
Clearance details
- Applicant
- Nova Biomedical Corporation
- Product code
- Code JGS
- Device class
- Class 2
- Regulation
- 21 CFR 862.1665
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Walham, MA, US
Recent devices under product code JGS
view allMore clearances from Nova Biomedical Corporation
view allAdverse events under product code JGS
product code JGS- Malfunction
- 535
- Total
- 535
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Recalls naming K200403
K-number listed on FDA's recall record- Z-0207-2024 — 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 Profile Prime Plus Analyzer, Remanufactured
- Z-0208-2024 — 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 63369 Stat Profile Prime Plus POC Analyzer, Remanufactured P/N: 57400, 63368
Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K200403.
Data sourced from openFDA. This site is unofficial and independent of the FDA.