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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 K001460
Device Name VIDAS H. PYLORI IGG (HPY) ASSAY, MODEL 30 192
Applicant
BIOMERIEUX, INC.
1022 HINGHAM ST.
ROCKLAND,  MA  02370
Applicant Contact JANET CONNOLLY
Correspondent
BIOMERIEUX, INC.
1022 HINGHAM ST.
ROCKLAND,  MA  02370
Correspondent Contact JANET CONNOLLY
Regulation Number866.3110
Classification Product Code
LYR  
Date Received05/10/2000
Decision Date 10/04/2000
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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