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FDA 510(k), K162642, Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
FDA 510(k), K162642, Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
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510(K) Number: K162642
Device Name: Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
Manufacturer: SARA HALLOWELL
Device Classification Name: Devices Detecting Influenza A, B, And C Virus Antigens
Regulation Number: PSZ
Classification Product Code: KXA
Date Received: 09/22/2016
Decision Date: 04/10/2017
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: Alere BinaxNOW Influenza A & B Card 2, Alere Reader, Alere BinaxNOW Influenza A & B Card 2 Control Swab Kit
Manufacturer: SARA HALLOWELL
Device Classification Name: Devices Detecting Influenza A, B, And C Virus Antigens
Regulation Number: PSZ
Classification Product Code: KXA
Date Received: 09/22/2016
Decision Date: 04/10/2017
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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