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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K865019
Device Name AFT(R) HEP PERFORMANCE EVALUATION PROGRAM
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
Date Received12/23/1986
Decision Date 02/10/1987
Decision Substantially Equivalent (SESE)
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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