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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 K010358
Device Name VIGIL SEROLOGY CONTROL LEVEL C
Applicant
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Applicant Contact ANNETTE HELLIE
Correspondent
Beckman Coulter, Inc.
200 S. Kraemer Blvd. W-110
Brea,  CA  92822
Correspondent Contact ANNETTE HELLIE
Regulation Number862.1660
Classification Product Code
JJY  
Date Received02/06/2001
Decision Date 03/05/2001
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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