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FDA 510(k), K021789, QUICKLAB RSV
FDA 510(k), K021789, QUICKLAB RSV
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510(K) Number: K021789
Device Name: QUICKLAB RSV
Manufacturer: SALLY A BOOTH
Device Classification Name: Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Regulation Number: GQG
Classification Product Code: 05/31/2002
Date Received: 11/20/2002
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Microbiology
Device Name: QUICKLAB RSV
Manufacturer: SALLY A BOOTH
Device Classification Name: Antigen, Cf (Including Cf Controls), Respiratory Syncytial Virus
Regulation Number: GQG
Classification Product Code: 05/31/2002
Date Received: 11/20/2002
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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