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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, Neisseria
510(k) Number K032194
Device Name TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS
Applicant
Gen-Probe, Inc.
10210 Genetic Center Dr.
San Diego,  CA  92121
Applicant Contact WAYNE A KVETKOSKY
Correspondent
Gen-Probe, Inc.
10210 Genetic Center Dr.
San Diego,  CA  92121
Correspondent Contact WAYNE A KVETKOSKY
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Code
MKZ  
Date Received07/18/2003
Decision Date 12/24/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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