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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dna-Probe, Haemophilus Spp.
510(k) Number K897079
Device Name ACCUPROBE HAEOMPHILUS INFLUENZAE CULTURE
Applicant
Gen-Probe, Inc.
9880 Campus Pt. Dr.
San Diego,  CA  92121
Applicant Contact BRUNI, PH.D.
Correspondent
Gen-Probe, Inc.
9880 Campus Pt. Dr.
San Diego,  CA  92121
Correspondent Contact BRUNI, PH.D.
Regulation Number866.3300
Classification Product Code
MCC  
Date Received12/22/1989
Decision Date 03/08/1990
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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