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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 K002023
Device Name MEDMIRA RAPID H. PYLORI ANTIBODY TEST, MODEL 10714
Applicant
MEDMIRA LABORATORIES, INC.
155 CHAIN LAKE DR.
HALIFAX, N.S.,  CA B3S 1B3
Applicant Contact TODD BISHOP
Correspondent
MEDMIRA LABORATORIES, INC.
155 CHAIN LAKE DR.
HALIFAX, N.S.,  CA B3S 1B3
Correspondent Contact TODD BISHOP
Regulation Number866.3110
Classification Product Code
LYR  
Date Received07/03/2000
Decision Date 11/13/2000
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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