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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Prealbumin, Antigen, Antiserum, Control
510(k) Number K851912
Device Name LASER PREALBUMIN TEST
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 Number866.5060
Classification Product Code
JZJ  
Date Received05/01/1985
Decision Date 06/21/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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