AUDIT MICROCV T-UPTAKE LINEARITY— 510(k) K112143

Substantially Equivalent

Aalto Scientific, Ltd.

FDA 510(k) clearance K112143 for AUDIT MICROCV T-UPTAKE LINEARITY, Substantially Equivalent on 2012-01-31. Applicant: Aalto Scientific, Ltd..

Clearance details

Applicant: Aalto Scientific, Ltd.
Product code: Code JJX
Advisory panel: Clinical Chemistry
Date received: 2011-07-26
Decision date: 2012-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Carlsbad, CA, 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.