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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 K831871
Device Name SICKLE-HEME A/S CONTROLS & A/A CONTROL
Applicant
Anco Medical Reagents & Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Anco Medical Reagents & Assoc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.7825
Classification Product Code
GHM  
Date Received06/13/1983
Decision Date 07/28/1983
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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