HAVAb IgG II— 510(k) K222850

Substantially Equivalent

Abbott Laboratories

FDA 510(k) clearance K222850 for HAVAb IgG II, Substantially Equivalent on 2023-08-10. Applicant: Abbott Laboratories. Device class: 2.

Clearance details

Applicant: Abbott Laboratories
Product code: Code LOL
Device class: Class 2
Regulation: 21 CFR 866.3310
Advisory panel: Microbiology
Date received: 2022-09-21
Decision date: 2023-08-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Abbott Park, 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.