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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antiserum, Fluorescent, Chlamydia Trachomatis
510(k) Number K871278
Device Name MODIFIED CHLAMYDIA 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 Number866.3120
Classification Product Code
LJP  
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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