LTX · Class II · 21 CFR 866.1620

FDA Product Code LTX: Discs, Elution

Leading manufacturers include Ab Biodisk.

2
Total
2
Cleared
92d
Avg days
1999
Since

FDA 510(k) Cleared Discs, Elution Devices (Product Code LTX)

2 devices
1–2 of 2
Cleared Nov 08, 2000
ETEST LINEZOLID
K002139
Ab Biodisk
Microbiology · 114d
Cleared Nov 16, 1999
ETEST FOR QUINUPRISTIN/DALFOPRISTIN
K992993
Ab Biodisk
Microbiology · 70d

About Product Code LTX - Regulatory Context