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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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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