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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cell Enzymes (Erythrocytic And Leukocytic)
510(k) Number K822733
Device Name SIGMA REAGENT SYSTEM NO. 885
Applicant
Sigma Chemical Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Correspondent
Sigma Chemical Co.
4221 Richmond Rd., NW
Walker,  MI  49534
Regulation Number864.7100
Classification Product Code
JBE  
Date Received09/08/1982
Decision Date 12/03/1982
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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