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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 K853906
Device Name LIQUI-SERA CHEMISTRY CONTROLS (COMPREHENSIVE)
Applicant
Biodiagnostic Intl
1251 - Q S. Beach Blvd.
La Habra,  CA  90631
Applicant Contact PAUL ANAND
Correspondent
Biodiagnostic Intl
1251 - Q S. Beach Blvd.
La Habra,  CA  90631
Correspondent Contact PAUL ANAND
Regulation Number862.1660
Classification Product Code
JJY  
Date Received09/20/1985
Decision Date 10/04/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
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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