CHEMPRO 1000— 510(k) K854260
Substantially EquivalentSen Tech Medical Corp.
FDA 510(k) clearance K854260 for CHEMPRO 1000, Substantially Equivalent on 1985-11-19. Applicant: Sen Tech Medical Corp..
Clearance details
- Applicant
- Sen Tech Medical Corp.
- Product code
- Code CGA
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Arden Hills, MN, US
Adverse events under product code CGA
product code CGA- Death
- 2
- Malfunction
- 1,816
- Total
- 1,818
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 →
Data sourced from openFDA. This site is unofficial and independent of the FDA.