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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 K955755
Device Name TREND CRYPTOSPORIDIUM DETECTION TEST SYSTEMS
Applicant
Trend Scientific, Inc.
368 W. County Rd. D
New Brighton,  MN  55112
Applicant Contact MARIELLYN TRUAX
Correspondent
Trend Scientific, Inc.
368 W. County Rd. D
New Brighton,  MN  55112
Correspondent Contact MARIELLYN TRUAX
Regulation Number866.3220
Classification Product Code
MHJ  
Date Received12/20/1995
Decision Date 07/11/1996
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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