LSE · Class I · 21 CFR 866.3235

FDA Product Code LSE: Epstein-barr Virus, Other

Leading manufacturers include Biokit, S.A..

56
Total
56
Cleared
173d
Avg days
1988
Since
Growing category - 1 submissions in the last 2 years vs 0 in the prior period
Review times increasing: avg 272d recently vs 172d historically

FDA 510(k) Cleared Epstein-barr Virus, Other Devices (Product Code LSE)

56 devices
1–24 of 56
Cleared Aug 07, 2024
ADVIA Centaur EBV-VCA IgM
K233606
Biokit, S.A.
Microbiology · 272d

About Product Code LSE - Regulatory Context

510(k) Submission Activity

56 total 510(k) submissions under product code LSE since 1988, with 56 receiving FDA clearance (average review time: 173 days).

Submission volume has increased in recent years - 1 submissions in the last 24 months compared to 0 in the prior period - suggesting growing market activity in this device classification.

FDA Review Time

Recent submissions under LSE have taken an average of 272 days to reach a decision - up from 172 days historically. Manufacturers should account for longer review timelines in current project planning.

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