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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Campylobacter Spp.
510(k) Number K982315
Device Name PROSPECT CAMPYLOBACTER MICROPLATE ASSAY
Applicant
Alexon - Trend, Inc.
14000 Unity St. NW
Ramsey,  MN  55303
Applicant Contact KEN HOOD
Correspondent
Alexon - Trend, Inc.
14000 Unity St. NW
Ramsey,  MN  55303
Correspondent Contact KEN HOOD
Regulation Number866.3110
Classification Product Code
LQP  
Date Received07/01/1998
Decision Date 11/18/1998
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
Recalls CDRH Recalls
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