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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagent, Borrelia Serological Reagent
510(k) Number K965131
Device Name BORRELIA BURGDORFERI IGG/IGM ELISA TEST SYSTEM
Applicant
Wampole Laboratories
Div. Of Carter-Wallace, Inc.
366 Princetone-Hightstown Rd.
Cranbury,  NJ  08512
Applicant Contact WILLIAM L BOTELER JR.
Correspondent
Wampole Laboratories
Div. Of Carter-Wallace, Inc.
366 Princetone-Hightstown Rd.
Cranbury,  NJ  08512
Correspondent Contact WILLIAM L BOTELER JR.
Regulation Number866.3830
Classification Product Code
LSR  
Date Received12/23/1996
Decision Date 03/26/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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