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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigen, Latex Agglutination, Trichinella Spiralis
510(k) Number K882149
Device Name MINIFUGE, MODEL 70
Applicant
Utah Bioresearch, Inc.
Suite 222
410 Chipeta Way
Salt Lake City,  UT  84108
Applicant Contact WILLIAM S PARTRIDGE
Correspondent
Utah Bioresearch, Inc.
Suite 222
410 Chipeta Way
Salt Lake City,  UT  84108
Correspondent Contact WILLIAM S PARTRIDGE
Regulation Number866.3850
Classification Product Code
GPG  
Date Received05/23/1988
Decision Date 07/01/1988
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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