Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075)— 510(k) K212778

Name: FDA 510(k) clearance K212778
Creator: U.S. Food and Drug Administration
Published: 2022-07-15

Substantially Equivalent

Abbott Molecular, Inc.

FDA 510(k) clearance K212778 for Alinity m EBV AMP Kit (List No. 09N43-095), Alinity m EBV CTRL Kit (List No. 09N43-085), Alinity m EBV CAL Kit (List No. 09N43-075), Substantially Equivalent on 2022-07-15. Applicant: Abbott Molecular, Inc.. Device class: 2.

Clearance details

Applicant: Abbott Molecular, Inc.
Product code: Code QLX
Device class: Class 2
Regulation: 21 CFR 866.3183
Advisory panel: Microbiology
Date received: 2021-09-01
Decision date: 2022-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Des Plaines, IL, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.