Multichem A1c— 510(k) K162514

Name: FDA 510(k) clearance K162514
Creator: U.S. Food and Drug Administration
Published: 2016-10-26

Substantially Equivalent

Technopath Manufacturing

FDA 510(k) clearance K162514 for Multichem A1c, Substantially Equivalent on 2016-10-26. Applicant: Technopath Manufacturing. Device class: 1.

Clearance details

Applicant: Technopath Manufacturing
Product code: Code JJX
Device class: Class 1
Regulation: 21 CFR 862.1660
Advisory panel: Clinical Chemistry
Date received: 2016-09-08
Decision date: 2016-10-26
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Ballina, IE

Download summary PDF View on FDA.gov ↗

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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.