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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Kit, Screening, Trichomonas
510(k) Number K020595
Device Name XENOSTRIP-TV TRICHOMONAS CASSETTE TEST, MODEL C1383.01
Applicant
Xenotope Diagnostics, Inc.
9418 Lasaine Ave.
Northridge,  CA  91325
Applicant Contact ROBIN J HELLEN
Correspondent
Xenotope Diagnostics, Inc.
9418 Lasaine Ave.
Northridge,  CA  91325
Correspondent Contact ROBIN J HELLEN
Regulation Number866.2660
Classification Product Code
JWZ  
Date Received02/22/2002
Decision Date 02/20/2003
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
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