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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 K883666
Device Name QUIDEL ALLERGY SCREEN
Applicant
Quidel Corp.
10165 Mckellar Ct.
San Diego,  CA  92121
Applicant Contact Robin Weiner
Correspondent
Quidel Corp.
10165 Mckellar Ct.
San Diego,  CA  92121
Correspondent Contact Robin Weiner
Regulation Number866.5750
Classification Product Code
DHB  
Date Received08/26/1988
Decision Date 10/18/1988
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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