VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT— 510(k) K133550
Substantially EquivalentMaine Standards Company, LLC
FDA 510(k) clearance K133550 for VALIDATE FERRITIN CALIBRATION VERIFICATION/ LINEARITY TEST KIT, Substantially Equivalent on 2014-02-05. Applicant: Maine Standards Company, LLC.
Clearance details
- Applicant
- Maine Standards Company, LLC
- Product code
- Code JJX
- Advisory panel
- Clinical Chemistry
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Cumberland Foreside, 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.