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FDA 510(k), K190428, Elecsys Anti-HAV II
FDA 510(k), K190428, Elecsys Anti-HAV II
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510(K) Number: K190428
Device Name: Elecsys Anti-HAV II
Manufacturer: Jamie Ferguson
Device Classification Name: Hepatitis A Test (Antibody And Igm Antibody)
Regulation Number: LOL
Classification Product Code: 02/22/2019
Date Received: 08/13/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: Elecsys Anti-HAV II
Manufacturer: Jamie Ferguson
Device Classification Name: Hepatitis A Test (Antibody And Igm Antibody)
Regulation Number: LOL
Classification Product Code: 02/22/2019
Date Received: 08/13/2019
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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