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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 K113397
Device Name ZEUS ELISA BORRELIA VLSE-1/PEPC10 IGG/IGM TEST SYSTEM
Applicant
ZEUS SCIENTIFIC, INC.
200 EVANS WAY
BRANCHBURG,  NJ  08876
Applicant Contact EWA NADOLCZAK
Correspondent
ZEUS SCIENTIFIC, INC.
200 EVANS WAY
BRANCHBURG,  NJ  08876
Correspondent Contact EWA NADOLCZAK
Regulation Number866.3830
Classification Product Code
LSR  
Date Received11/17/2011
Decision Date 07/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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