LFY · Class II · 21 CFR 866.3900

FDA Product Code LFY: Enzyme Linked Immunoabsorbent Assay, Varicella-zoster

Leading manufacturers include DiaSorin, Inc..

17
Total
17
Cleared
181d
Avg days
1983
Since
Declining activity - 0 submissions in the last 2 years vs 1 in the prior period

FDA 510(k) Cleared Enzyme Linked Immunoabsorbent Assay, Varicella-zoster Devices (Product Code LFY)

17 devices
1–17 of 17
Cleared Oct 27, 2023
LIAISON VZV IgG HT, LIAISON Control VZV IgG HT
K231214
DiaSorin, Inc.
Microbiology · 182d

About Product Code LFY - Regulatory Context

510(k) Submission Activity

17 total 510(k) submissions under product code LFY since 1983, with 17 receiving FDA clearance (average review time: 181 days).

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

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