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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antigens, Ha, Treponema Pallidum
510(k) Number K971502
Device Name SERODIA TP-PA
Applicant
Scimedx Tekfile Services
400 Ford Rd.
Denvill,  NJ  07834
Applicant Contact Gary Lehnus
Correspondent
Scimedx Tekfile Services
400 Ford Rd.
Denvill,  NJ  07834
Correspondent Contact Gary Lehnus
Regulation Number866.3830
Classification Product Code
GMT  
Date Received04/24/1997
Decision Date 11/13/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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