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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Giardia Spp.
510(k) Number K953284
Device Name TREND GIARDIA DIRECT DETECTION RS TEST SYSTEM
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
MHI  
Date Received07/13/1995
Decision Date 10/06/1995
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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