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FDA 510(k), K172322, Atellica IM Total hCG (ThCG)
FDA 510(k), K172322, Atellica IM Total hCG (ThCG)
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510(K) Number: K172322
Device Name: Atellica IM Total hCG (ThCG)
Manufacturer: Siemens Healthcare Diagnostics Inc.
Device Classification Name: visual, pregnancy hcg, prescription use
Regulation Number: 862.1155
Classification Product Code: JHI
Date Received: 08/01/2017
Decision Date: 03/29/2018
Regulation Medical Specialty: Clinical Chemistry
Device Name: Atellica IM Total hCG (ThCG)
Manufacturer: Siemens Healthcare Diagnostics Inc.
Device Classification Name: visual, pregnancy hcg, prescription use
Regulation Number: 862.1155
Classification Product Code: JHI
Date Received: 08/01/2017
Decision Date: 03/29/2018
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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