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FDA 510(k), K182001, Acucy Influenza A&B Test with the Acucy System
FDA 510(k), K182001, Acucy Influenza A&B Test with the Acucy System
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510(K) Number: K182001
Device Name: Acucy Influenza A&B Test with the Acucy System
Manufacturer: Shelly Harris
Device Classification Name: Devices Detecting Influenza A, B, And C Virus Antigens
Regulation Number: PSZ
Classification Product Code: KXA
Date Received: 07/26/2018
Decision Date: 12/17/2018
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: Acucy Influenza A&B Test with the Acucy System
Manufacturer: Shelly Harris
Device Classification Name: Devices Detecting Influenza A, B, And C Virus Antigens
Regulation Number: PSZ
Classification Product Code: KXA
Date Received: 07/26/2018
Decision Date: 12/17/2018
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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