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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cyanomethemoglobin
510(k) Number K894951
Device Name MODIFIED HEMOGLOBIN REAGENT SET
Applicant
Macomb Biotechnology, Inc.
70001 Powell Rd., P.O. Box 466
Romeo,  MI  48065
Applicant Contact PEGGY MOUNTS
Correspondent
Macomb Biotechnology, Inc.
70001 Powell Rd., P.O. Box 466
Romeo,  MI  48065
Correspondent Contact PEGGY MOUNTS
Regulation Number864.7500
Classification Product Code
GKK  
Date Received07/20/1989
Decision Date 10/24/1989
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
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