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FDA 510(k), K143325, OC-Light S FIT
FDA 510(k), K143325, OC-Light S FIT
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$149.00 USD
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510(K) Number: K143325
Device Name: OC-Light S FIT
Manufacturer: EIKEN CHEMICAL CO. LTD
Device Classification Name: reagent, occult blood
Regulation Number: 864.6550
Classification Product Code: KHE
Date Received: 11/20/2014
Decision Date: 08/20/2015
Regulation Medical Specialty: Hematology
Device Name: OC-Light S FIT
Manufacturer: EIKEN CHEMICAL CO. LTD
Device Classification Name: reagent, occult blood
Regulation Number: 864.6550
Classification Product Code: KHE
Date Received: 11/20/2014
Decision Date: 08/20/2015
Regulation Medical Specialty: Hematology
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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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