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FDA 510(k), K103529, LIAISON XL ANALYZER MODEL 10050
FDA 510(k), K103529, LIAISON XL ANALYZER MODEL 10050
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510(K) Number: K103529
Device Name: LIAISON XL ANALYZER MODEL 10050
Manufacturer: Mari Meyer
Device Classification Name: Hepatitis A Test (Antibody And Igm Antibody)
Regulation Number: LOL
Classification Product Code: KXA
Date Received: 12/01/2010
Decision Date: 01/21/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: LIAISON XL ANALYZER MODEL 10050
Manufacturer: Mari Meyer
Device Classification Name: Hepatitis A Test (Antibody And Igm Antibody)
Regulation Number: LOL
Classification Product Code: KXA
Date Received: 12/01/2010
Decision Date: 01/21/2011
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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