Elecsys Anti-HAV II
K-Number: K190428 · 2019-08-13
ApplicantRoche Diagnostics
Decision Date2019-08-13
Product CodeLOL
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
Elecsys Anti-HAV II is a medical device manufactured by Roche Diagnostics. It received FDA 510(k) clearance on 2019-08-13 under approval number K190428. 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 Elecsys Anti-HAV II?
Elecsys Anti-HAV II is a medical device that received FDA 510(k) clearance on 2019-08-13. It is manufactured by Roche Diagnostics. The 510(k) number is K190428.
When was Elecsys Anti-HAV II approved by the FDA?
Elecsys Anti-HAV II received FDA 510(k) clearance on 2019-08-13, under approval number K190428.
What company makes Elecsys Anti-HAV II?
Elecsys Anti-HAV II is manufactured by Roche Diagnostics.
What is the FDA product code for Elecsys Anti-HAV II?
The FDA product code for Elecsys Anti-HAV 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.