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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Helicobacter Pylori
510(k) Number K915851
Device Name QUIDEL QUICKVUE H. PYLORI CONTROLS (POS. AND NEG)
Applicant
Quidel Corp.
10165 Mckellar Ct.
San Diego,  CA  92121
Applicant Contact CRAIG WATSON
Correspondent
Quidel Corp.
10165 Mckellar Ct.
San Diego,  CA  92121
Correspondent Contact CRAIG WATSON
Regulation Number866.3110
Classification Product Code
LYR  
Date Received12/27/1991
Decision Date 02/21/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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