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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 K905049
Device Name QUIDEL HELICOBACTER PYLORI POSTIVE/NEGATIVE CONTR
Applicant
Quidel Corp.
10165 Mckellar Ct.
San Diego,  CA  92121
Applicant Contact CRAIG E WATSON
Correspondent
Quidel Corp.
10165 Mckellar Ct.
San Diego,  CA  92121
Correspondent Contact CRAIG E WATSON
Regulation Number866.3110
Classification Product Code
LYR  
Date Received11/08/1990
Decision Date 05/07/1991
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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