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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 K893124
Device Name OLYMPUS PK(TM) TP
Applicant
Fujirebio Diagnostics,Inc.
Schiff & Company
583 Mountain Ave.
North Caldwell,  NJ  07006
Applicant Contact JANE B CAMPBELL
Correspondent
Fujirebio Diagnostics,Inc.
Schiff & Company
583 Mountain Ave.
North Caldwell,  NJ  07006
Correspondent Contact JANE B CAMPBELL
Regulation Number866.3830
Classification Product Code
GMT  
Date Received04/25/1989
Decision Date 11/17/1989
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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