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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Calculator/Data Processing Module, For Clinical Use
510(k) Number K853026
Device Name BIOVATION MAX DATA MANAGEMENT SYSTEM
Applicant
Biovation, Inc.
4050 Lakeside Dr.
San Pablo,  CA  94806
Applicant Contact EDWIN O BROWN
Correspondent
Biovation, Inc.
4050 Lakeside Dr.
San Pablo,  CA  94806
Correspondent Contact EDWIN O BROWN
Regulation Number862.2100
Classification Product Code
JQP  
Date Received07/18/1985
Decision Date 08/02/1985
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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