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FDA 510(k), K060463, HEMA SCREEN SPECIFIC IFOBT
FDA 510(k), K060463, HEMA SCREEN SPECIFIC IFOBT
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510(K) Number: K060463
Device Name: HEMA SCREEN SPECIFIC IFOBT
Manufacturer: IMMUNOSTICS, INC.
Device Classification Name: reagent, occult blood
Regulation Number: 864.6550
Classification Product Code: KHE
Date Received: 02/22/2006
Decision Date: 06/06/2006
Regulation Medical Specialty: Hematology
Device Name: HEMA SCREEN SPECIFIC IFOBT
Manufacturer: IMMUNOSTICS, INC.
Device Classification Name: reagent, occult blood
Regulation Number: 864.6550
Classification Product Code: KHE
Date Received: 02/22/2006
Decision Date: 06/06/2006
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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