DeviceClearance

Product code LDP— Clinical Toxicology

ACA ACETAMINOPHEN ANALYTICAL TEST PACK

Classification name
Colorimetry, Acetaminophen
Device class
Class 2
Regulation
21 CFR 862.3030
Advisory panel
Clinical Toxicology
Total cleared
37
First cleared
Most recent

Market context for product code LDP

FDA has cleared 37 devices under product code LDP between 1980 and 2026, filed by 27 applicant companies. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.

Clearances per year

last 15 years

Top applicants under product code LDP

Adverse events under product code LDP

product code LDP
Other
1
Total
1

Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recent clearances under product code LDP

Data sourced from openFDA. This site is unofficial and independent of the FDA.