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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Radioallergosorbent (Rast) Immunological
510(k) Number K941278
Device Name HY-TEC AUTOMATED EIA SYSTEM
Applicant
Hycor Biomedical, Inc.
7272 Chapman Ave.
Garden Grove,  CA  92841
Applicant Contact THOMAS J FOLEY
Correspondent
Hycor Biomedical, Inc.
7272 Chapman Ave.
Garden Grove,  CA  92841
Correspondent Contact THOMAS J FOLEY
Regulation Number866.5750
Classification Product Code
DHB  
Date Received03/17/1994
Decision Date 03/13/1995
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
Recalls CDRH Recalls
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