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FDA 510(k), K860812, SICKLE CELL REAGENT SET
FDA 510(k), K860812, SICKLE CELL REAGENT SET
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510(K) Number: K860812
Device Name: SICKLE CELL REAGENT SET
Manufacturer: MICHCLONE ASSOCIATES, INC.
Device Classification Name: test, sickle cell
Regulation Number: 864.7825
Classification Product Code: GHM
Date Received: 03/04/1986
Decision Date: 04/11/1986
Regulation Medical Specialty: Hematology
Device Name: SICKLE CELL REAGENT SET
Manufacturer: MICHCLONE ASSOCIATES, INC.
Device Classification Name: test, sickle cell
Regulation Number: 864.7825
Classification Product Code: GHM
Date Received: 03/04/1986
Decision Date: 04/11/1986
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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