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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Multi-Analyte Controls, All Kinds (Assayed)
510(k) Number K852418
Device Name QCM-SP1(NORMAL CONCENTTRATION) & SP2(ABNORMAL)
Applicant
Amf Biological and Diagnostics Co.
1015 N. Austin
Seguin,  TX  78155
Applicant Contact DAVID H RAY
Correspondent
Amf Biological and Diagnostics Co.
1015 N. Austin
Seguin,  TX  78155
Correspondent Contact DAVID H RAY
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/07/1985
Decision Date 07/15/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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