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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 K875168
Device Name QUIDEL TOTAL IGE TEST
Applicant
Quidel Corp.
11077 N. Torrey Pines Rd.
La Jolla,  CA  92037
Applicant Contact MICHAEL KLICPERA
Correspondent
Quidel Corp.
11077 N. Torrey Pines Rd.
La Jolla,  CA  92037
Correspondent Contact MICHAEL KLICPERA
Regulation Number866.5750
Classification Product Code
DHB  
Date Received12/16/1987
Decision Date 03/18/1988
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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