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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name test, sickle cell
510(k) Number K860812
Device Name SICKLE CELL REAGENT SET
Applicant
MICHCLONE ASSOCIATES, INC.
15003 W 8 MILE
detroit,  MI  48235
Applicant Contact toben, phd
Correspondent
MICHCLONE ASSOCIATES, INC.
15003 W 8 MILE
detroit,  MI  48235
Correspondent Contact toben, phd
Regulation Number864.7825
Classification Product Code
GHM  
Date Received03/04/1986
Decision Date 04/11/1986
Decision substantially equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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