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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Nephelometer, For Clinical Use
510(k) Number K792045
Device Name BIOVATION NEPHELOMETER
Applicant
Biovation, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Biovation, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.2700
Classification Product Code
JQX  
Date Received10/12/1979
Decision Date 10/30/1979
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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