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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 K871279
Device Name MODIFIED TRICHOMONAS DIRECT SPECIMEN TEST KIT
Applicant
California Integrated Diagnostics, Inc.
1440 Fourth St.
Berkeley,  CA  94710
Applicant Contact MARK S TANAKA
Correspondent
California Integrated Diagnostics, Inc.
1440 Fourth St.
Berkeley,  CA  94710
Correspondent Contact MARK S TANAKA
Regulation Number866.2660
Classification Product Code
JWZ  
Date Received03/31/1987
Decision Date 04/08/1987
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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