HAVAb IgG II
K-Number: K222850 · 2023-08-10
ApplicantAbbott Laboratories
Decision Date2023-08-10
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
HAVAb IgG II is a medical device manufactured by Abbott Laboratories. It received FDA 510(k) clearance on 2023-08-10 under approval number K222850. The device is classified under product code LOL. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the HAVAb IgG II?
HAVAb IgG II is a medical device that received FDA 510(k) clearance on 2023-08-10. It is manufactured by Abbott Laboratories. The 510(k) number is K222850.
When was HAVAb IgG II approved by the FDA?
HAVAb IgG II received FDA 510(k) clearance on 2023-08-10, under approval number K222850.
What company makes HAVAb IgG II?
HAVAb IgG II is manufactured by Abbott Laboratories.
What is the FDA product code for HAVAb IgG II?
The FDA product code for HAVAb IgG II is LOL.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.