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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
Recalls CDRH Recalls
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