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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 K864128
Device Name CHLAMYDIA-CHECK(TM) DIRECT & CULTURE CONFIR. KIT
Applicant
Diagnostic Technology, Inc.
240 Vanderbilt Motor Pkwy.
Hauppauge,  NY  11788
Applicant Contact ROBERT E LIND
Correspondent
Diagnostic Technology, Inc.
240 Vanderbilt Motor Pkwy.
Hauppauge,  NY  11788
Correspondent Contact ROBERT E LIND
Regulation Number866.3120
Classification Product Code
LJP  
Date Received10/21/1986
Decision Date 04/29/1987
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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