VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406— 510(k) K123127

Substantially Equivalent

Maine Standards Co.

FDA 510(k) clearance K123127 for VALIDATE PSA CALIBRATION VERIFICATION/ LINEARITY TEST KIT MODEL 406, Substantially Equivalent on 2013-06-14. Applicant: Maine Standards Co..

Clearance details

Applicant: Maine Standards Co.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2012-10-04
Decision date: 2013-06-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Windham, ME, US

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Adverse events under product code JJX

product code JJX

Other: 2
Total: 2

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. 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.