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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Enzyme Linked Immunoabsorption Assay, Treponema Pallidum
510(k) Number K895964
Device Name DCL SYPHILIS-M CATALOG NO. 600-80
Applicant
Diagnostic Chemicals, Ltd. (Usa)
160 Christian St.
Oxford,  CT  06478
Applicant Contact DAVID TEMPLETON
Correspondent
Diagnostic Chemicals, Ltd. (Usa)
160 Christian St.
Oxford,  CT  06478
Correspondent Contact DAVID TEMPLETON
Regulation Number866.3830
Classification Product Code
LIP  
Date Received10/11/1989
Decision Date 01/08/1991
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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