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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna-Reagents, Legionella
510(k) Number K860498
Device Name GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM
Applicant
Gen-Probe, Inc.
9620 Chesapeake Dr.
San Diego,  CA  92123
Applicant Contact KACIAN, PH.D.
Correspondent
Gen-Probe, Inc.
9620 Chesapeake Dr.
San Diego,  CA  92123
Correspondent Contact KACIAN, PH.D.
Regulation Number866.3300
Classification Product Code
LQH  
Date Received02/10/1986
Decision Date 07/16/1986
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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