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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Apolipoproteins
510(k) Number K850638
Device Name LASER APO A-I TEST APOLIPOPROTEIN A-I REAGENTS
Applicant
Behring Diagnostics, Inc.
10933 No Torrey Pines Rd.
La Jolla,  CA  92037
Applicant Contact JOHN E HUGHES
Correspondent
Behring Diagnostics, Inc.
10933 No Torrey Pines Rd.
La Jolla,  CA  92037
Correspondent Contact JOHN E HUGHES
Regulation Number862.1475
Classification Product Code
MSJ  
Date Received02/19/1985
Decision Date 05/15/1985
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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