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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 K984544
Device Name THE APTUS (AUTOMATED) APPLICATION OF THE HM-CAP EIA KIT. AN ENZYME LINKED IMMUNOSORBENT ASSAY FOR THE DETECTION OF THE S
Applicant
Enteric Products, Inc.
25 E. Loop Dr.
Stony Brook,  NY  11790
Applicant Contact JEFFREY PEACOCK
Correspondent
Enteric Products, Inc.
25 E. Loop Dr.
Stony Brook,  NY  11790
Correspondent Contact JEFFREY PEACOCK
Regulation Number866.3110
Classification Product Code
LYR  
Date Received12/22/1998
Decision Date 02/18/1999
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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