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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 K882199
Device Name CLOTEST, CAMPYLOBACTER PYLORI UREASE ENZYME TEST
Applicant
Auspharm Intl. , Ltd.
979 Julius Ct.
North Merrick,  NY  11566
Applicant Contact FRED LANDSMAN
Correspondent
Auspharm Intl. , Ltd.
979 Julius Ct.
North Merrick,  NY  11566
Correspondent Contact FRED LANDSMAN
Regulation Number866.3110
Classification Product Code
LYR  
Date Received05/25/1988
Decision Date 10/06/1988
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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