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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Test, Pregnancy, Hcg, Over The Counter
510(k) Number K862207
Device Name QUIDEL BETA STICK PREGNANCY TEST (MODIFICATION)
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 Number862.1155
Classification Product Code
LCX  
Date Received06/10/1986
Decision Date 06/17/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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