LDP · Class II · 21 CFR 862.3030

FDA Product Code LDP: Colorimetry, Acetaminophen

Leading manufacturers include Sekisui Diagnostics P.E.I., Inc..

36
Total
36
Cleared
97d
Avg days
1980
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Colorimetry, Acetaminophen Devices (Product Code LDP)

36 devices
1–24 of 36
Cleared Feb 18, 2022
Acetaminophen
K202644
Sekisui Diagnostics P.E.I., Inc.
Toxicology · 525d

About Product Code LDP - Regulatory Context

510(k) Submission Activity

36 total 510(k) submissions under product code LDP since 1980, with 36 receiving FDA clearance (average review time: 97 days).

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

LDP devices are reviewed by the Toxicology panel. Browse all Toxicology devices →