GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM

Dna-reagents, Legionella

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Legionella Rapid Diagnostic System.

Pre-market Notification Details

Device IDK860498
510k NumberK860498
Device Name:GEN-PROBE LEGIONELLA RAPID DIAGNOSTIC SYSTEM
ClassificationDna-reagents, Legionella
Applicant GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego,  CA  92123
ContactKacian, Ph.d.
CorrespondentKacian, Ph.d.
GEN-PROBE, INC. 9620 CHESAPEAKE DR. San Diego,  CA  92123
Product CodeLQH  
CFR Regulation Number866.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1986-02-10
Decision Date1986-07-16

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