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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 K850158
Device Name CHLAMYDIA FLUORO-KIT 1680
Applicant
Clinical Sciences, Inc.
30 Troy Rd.
Whippany,  NJ  07981
Applicant Contact MARYLOU PANICO
Correspondent
Clinical Sciences, Inc.
30 Troy Rd.
Whippany,  NJ  07981
Correspondent Contact MARYLOU PANICO
Regulation Number866.3120
Classification Product Code
LJP  
Date Received01/15/1985
Decision Date 03/21/1985
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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