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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 K844582
Device Name SYNCOR TECH CHLAMYDIA TISSUE CULTURE TEST
Applicant
Syncor Intl. Corp.
12847 Arroyo St.
Sylmar,  CA  91342
Applicant Contact ELEANOR V CHIU
Correspondent
Syncor Intl. Corp.
12847 Arroyo St.
Sylmar,  CA  91342
Correspondent Contact ELEANOR V CHIU
Regulation Number866.3120
Classification Product Code
LJP  
Date Received11/23/1984
Decision Date 01/16/1985
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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