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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Antisera, Fluorescent, All Types, Hemophilus Spp.
510(k) Number K851271
Device Name LEGIONELLA CULTURE CONFIRMATIN KIT
Applicant
Gen-Probe, Inc.
9620 Chesapeake Dr.
San Diego,  CA  92123
Applicant Contact THOMAS H ADAMS
Correspondent
Gen-Probe, Inc.
9620 Chesapeake Dr.
San Diego,  CA  92123
Correspondent Contact THOMAS H ADAMS
Regulation Number866.3300
Classification Product Code
GRO  
Date Received04/01/1985
Decision Date 07/08/1985
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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