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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 K872903
Device Name MICROTRAK CHLAMYDIA TRACHO. TEST - METHANOL FIXAT.
Applicant
Syva Co.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Applicant Contact ELEANOR V CHIU
Correspondent
Syva Co.
900 Arastradero Rd.
P.O. Box 10058
Palo Alto,  CA  94303
Correspondent Contact ELEANOR V CHIU
Regulation Number866.3120
Classification Product Code
LJP  
Date Received07/27/1987
Decision Date 08/06/1987
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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