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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ige, Antigen, Antiserum, Control
510(k) Number K861171
Device Name QUIDEL ALLERGY SCREEN
Applicant
Quidel Corp.
11077 N. Torrey Pines Rd.
La Jolla,  CA  92037
Applicant Contact ALBERT B SNYDER
Correspondent
Quidel Corp.
11077 N. Torrey Pines Rd.
La Jolla,  CA  92037
Correspondent Contact ALBERT B SNYDER
Regulation Number866.5510
Classification Product Code
DGC  
Date Received03/28/1986
Decision Date 04/25/1986
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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