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FDA 510(k), K173691, Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
FDA 510(k), K173691, Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
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510(K) Number: K173691
Device Name: Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
Manufacturer: Jennifer S. Rial
Device Classification Name: Reagent, Borrelia Serological Reagent
Regulation Number: LSR
Classification Product Code: 12/01/2017
Date Received: 02/28/2018
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: Sofia Lyme FIA, Sofia 2 analyzer, Sofia 2 Installation Pack
Manufacturer: Jennifer S. Rial
Device Classification Name: Reagent, Borrelia Serological Reagent
Regulation Number: LSR
Classification Product Code: 12/01/2017
Date Received: 02/28/2018
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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