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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Extractable Antinuclear Antibody, Antigen And Control
510(k) Number K962578
Device Name HYCOR HY.TEC/MANUAL SS-B AUTO-ANTIBODY
Applicant
Hycor Biomedical, Inc.
7272 Chapman Ave.
Garden Grove,  CA  92841
Applicant Contact MEHDI ALEM, PH.D.
Correspondent
Hycor Biomedical, Inc.
7272 Chapman Ave.
Garden Grove,  CA  92841
Correspondent Contact MEHDI ALEM, PH.D.
Regulation Number866.5100
Classification Product Code
LLL  
Date Received07/01/1996
Decision Date 03/07/1997
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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