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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Urease And Glutamic Dehydrogenase, Urea Nitrogen
510(k) Number K851513
Device Name ULTRA-VIOLET BUN REAGENT KIT
Applicant
Bio-Analytics Laboratories, Inc.
One Bio-Analytics Pl.
Box 333
Palm City,  FL  33490
Applicant Contact ROY
Correspondent
Bio-Analytics Laboratories, Inc.
One Bio-Analytics Pl.
Box 333
Palm City,  FL  33490
Correspondent Contact ROY
Regulation Number862.1770
Classification Product Code
CDQ  
Date Received04/15/1985
Decision Date 05/20/1985
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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