LSL · Class II · 21 CFR 866.3390

FDA Product Code LSL: Dna-reagents, Neisseria

Leading manufacturers include Hologic, Inc..

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

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.

LSL devices are reviewed by the Microbiology panel. Browse all Microbiology devices →