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FDA 510(k), K092330, OC-SENSOR DIANA IFOB TEST
FDA 510(k), K092330, OC-SENSOR DIANA IFOB TEST
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510(K) Number: K092330
Device Name: OC-SENSOR DIANA IFOB TEST
Manufacturer: EIKEN CHEMICAL CO., LTD.
Device Classification Name: Automated Occult Blood Analyzer
Regulation Number: 864.6550
Classification Product Code: OOX
Date Received: 08/04/2009
Decision Date: 01/08/2010
Regulation Medical Specialty: Hematology
Device Name: OC-SENSOR DIANA IFOB TEST
Manufacturer: EIKEN CHEMICAL CO., LTD.
Device Classification Name: Automated Occult Blood Analyzer
Regulation Number: 864.6550
Classification Product Code: OOX
Date Received: 08/04/2009
Decision Date: 01/08/2010
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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