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FDA 510(k), K110701, ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
FDA 510(k), K110701, ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
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$149.00 USD
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$149.00 USD
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510(K) Number: K110701
Device Name: ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
Manufacturer: DNA GENOTEK INC
Device Classification Name: dna specimen collection, saliva
Regulation Number: 862.1675
Classification Product Code: OYJ
Date Received: 03/14/2011
Decision Date: 12/02/2011
Regulation Medical Specialty: Clinical Chemistry
Device Name: ORAGENE-DX OGD-500; ORAGENE-DX OGD-575; ORAGENE-DX OXD-525; ORAGENE-DX OYD-500
Manufacturer: DNA GENOTEK INC
Device Classification Name: dna specimen collection, saliva
Regulation Number: 862.1675
Classification Product Code: OYJ
Date Received: 03/14/2011
Decision Date: 12/02/2011
Regulation Medical Specialty: Clinical Chemistry
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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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