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FDA 510(k), K110035, INDIKO
FDA 510(k), K110035, INDIKO
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510(K) Number: K110035
Device Name: INDIKO
Manufacturer: PAIVI SORMUNEN
Device Classification Name: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Regulation Number: JJE
Classification Product Code: 01/05/2011
Date Received: 06/28/2011
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Clinical Chemistry
Device Name: INDIKO
Manufacturer: PAIVI SORMUNEN
Device Classification Name: Analyzer, Chemistry (Photometric, Discrete), For Clinical Use
Regulation Number: JJE
Classification Product Code: 01/05/2011
Date Received: 06/28/2011
Decision Date: Substantially Equivalent (SESE)
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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