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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 K872303
Device Name UNASSAYED CONTROL SERUM, ABNORMAL (BOVINE)
Applicant
Vanguard Diagnostic Systems
P.O. Box 3658
La Habra,  CA  90632
Applicant Contact LARRY BEATY
Correspondent
Vanguard Diagnostic Systems
P.O. Box 3658
La Habra,  CA  90632
Correspondent Contact LARRY BEATY
Regulation Number862.1660
Classification Product Code
JJY  
Date Received06/15/1987
Decision Date 07/07/1987
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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