LSL

Dna-Reagents, Neisseria

Product code: LSL
Device name: Dna-Reagents, Neisseria
Device class: Class 2
21 CFR: 21 CFR 866.3390
Medical specialty: Microbiology
Marketing pathway: 510(K)
510(k) clearances (last 3 years): 1
Summaries archived here: 1 (direct download)
510(k) clearances (all years, FDA): 45 (all years; only the last 3 years are listed here)

510(k) clearances, last 3 years (1)

Last three years. Most recent: 2024-01-26.

Number	Decision date	Applicant	Device name	Summary
K231329	2024-01-26	Hologic, Inc.	Aptima Neisseria gonorrhoeae Assay	PDF

1 summaries are archived here for direct download.

Official FDA classification page: LSL

Classification and pathway per current FDA publications. Data from openFDA (CC0).