VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005— 510(k) K012122
Substantially EquivalentMaine Standards Co.
FDA 510(k) clearance K012122 for VALIDATE CHEM 5 CALIBRATION VERIFICATION TEST SET, MODEL 10005, Substantially Equivalent on 2001-08-20. Applicant: Maine Standards Co..
Clearance details
- Applicant
- Maine Standards Co.
- Product code
- Code JJX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Windham, ME, US
Adverse events under product code JJX
product code JJX- Other
- 2
- Total
- 2
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.