GEN-PROBE APTIMA COMBO 2 ASSAY

Dna-reagents, Neisseria

GEN-PROBE, INC.

The following data is part of a premarket notification filed by Gen-probe, Inc. with the FDA for Gen-probe Aptima Combo 2 Assay.

Pre-market Notification Details

Device IDK043224
510k NumberK043224
Device Name:GEN-PROBE APTIMA COMBO 2 ASSAY
ClassificationDna-reagents, Neisseria
Applicant GEN-PROBE, INC. 10210 GENETIC CENTER DR. San Diego,  CA  92121 -4362
ContactAlan Maderazo
CorrespondentAlan Maderazo
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 Received2004-11-22
Decision Date2005-08-09
Summary:summary

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.