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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cryptosporidium Spp.
510(k) Number K982709
Device Name MODIFICATION TO PROSPECT CRYPTOSPORIDIUM MICROTITER 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 Number866.3220
Classification Product Code
MHJ  
Date Received08/04/1998
Decision Date 09/03/1998
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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