LKP · Class II · 21 CFR 866.5100

FDA Product Code LKP: Anti-sm Antibody, Antigen And Control

Leading manufacturers include Bio-Rad and Phadia AB.

28
Total
28
Cleared
99d
Avg days
1984
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Anti-sm Antibody, Antigen And Control Devices (Product Code LKP)

28 devices
1–24 of 28
Cleared Jul 14, 2021
EliA SmDP-S
K202067
Phadia AB
Immunology · 352d
Cleared Dec 24, 2018
EliA SmDP Immunoassay
K183007
Phadia AB
Immunology · 54d
Cleared Jan 15, 2003
LIQUICHEK ANTI-SM CONTROL, POSITIVE, CATALOG #115
K024219
Bio-Rad
Immunology · 23d
Cleared Dec 22, 1998
LIQUICHEK ANTI-SM CONTROL, EIA, MODEL 208
K984479
Bio-Rad
Immunology · 6d

About Product Code LKP - Regulatory Context

510(k) Submission Activity

28 total 510(k) submissions under product code LKP since 1984, with 28 receiving FDA clearance (average review time: 99 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.