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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Reagents, Antibody, Legionella, Direct & Indirect Fluorescent
510(k) Number K970149
Device Name LEGIONELLA ELISA TEST SYSTEM
Applicant
ZEUS SCIENTIFIC, INC.
P.O. BOX 38
RARITAN,  NJ  08869
Applicant Contact MARK J KEPNITSKY
Correspondent
ZEUS SCIENTIFIC, INC.
P.O. BOX 38
RARITAN,  NJ  08869
Correspondent Contact MARK J KEPNITSKY
Regulation Number866.3300
Classification Product Code
LHL  
Date Received01/15/1997
Decision Date 06/18/1997
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
Recalls CDRH Recalls
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