TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS

Dna-reagents, Neisseria

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Tigris Dts Automated Analyzer For Automating Amplified Nucleic Acid Test Assays.

Pre-market Notification Details

Device IDK032194
510k NumberK032194
Device Name:TIGRIS DTS AUTOMATED ANALYZER FOR AUTOMATING AMPLIFIED NUCLEIC ACID TEST ASSAYS
ClassificationDna-reagents, Neisseria
Applicant GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego,  CA  92121 -4362
ContactWayne A Kvetkosky
CorrespondentWayne A Kvetkosky
GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego,  CA  92121 -4362
Product CodeLSL  
CFR Regulation Number866.3390 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-07-18
Decision Date2003-12-24

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