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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 K874259
Device Name TRICHOMONAS DIRECT ENZYME IMMUNOASSAY
Applicant
California Integrated Diagnostics, Inc.
1440 Fourth St.
Berkeley,  CA  94710
Applicant Contact GARY J CASARETTO
Correspondent
California Integrated Diagnostics, Inc.
1440 Fourth St.
Berkeley,  CA  94710
Correspondent Contact GARY J CASARETTO
Regulation Number866.2660
Classification Product Code
JWZ  
Date Received10/20/1987
Decision Date 12/07/1987
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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