LSL · Class II · 21 CFR 866.3390

FDA Product Code LSL: Dna-reagents, Neisseria

Leading manufacturers include Hologic, Inc., Roche Diagnostics Corp. and Cepheid.

45
Total
45
Cleared
215d
Avg days
1987
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Dna-reagents, Neisseria Devices (Product Code LSL)

45 devices
1–24 of 45
Cleared Jan 26, 2024
Aptima Neisseria gonorrhoeae Assay
K231329
Hologic, Inc.
Microbiology · 263d
Cleared Jun 13, 2018
Aptima Combo 2 Assay (Panther System)
K180681
Hologic, Inc.
Microbiology · 90d
Cleared Mar 21, 2018
cobas CT/NG for use on cobas 6800/8800 systems
K173887
Roche Molecular Systems, Inc.
Microbiology · 90d
Cleared Mar 16, 2018
Xpert CT/NG
K173840
Cepheid
Microbiology · 88d
Cleared Aug 10, 2006
COBAS AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
K053289
Roche Diagnostics Corp.
Microbiology · 258d
Cleared May 06, 1996
LCX NEISSERIA GONORRHOEAE ASSAY
K935833
Abbott Laboratories
Microbiology · 881d

About Product Code LSL - Regulatory Context

510(k) Submission Activity

45 total 510(k) submissions under product code LSL since 1987, with 45 receiving FDA clearance (average review time: 215 days).

Submission volume has declined in recent years - 0 submissions in the last 24 months compared to 1 in the prior period.