Cleared Traditional

Acetaminophen

K202644 · Sekisui Diagnostics P.E.I., Inc. · Toxicology
Feb 2022
Decision
525d
Days
Class 2
Risk

About This 510(k) Submission

K202644 is an FDA 510(k) clearance for the Acetaminophen, a Colorimetry, Acetaminophen (Class II — Special Controls, product code LDP), submitted by Sekisui Diagnostics P.E.I., Inc. (Charlottetown, CA). The FDA issued a Cleared decision on February 18, 2022, 525 days after receiving the submission on September 11, 2020. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3030.

Submission Details

510(k) Number K202644 FDA.gov
FDA Decision Cleared SESE
Date Received September 11, 2020
Decision Date February 18, 2022
Days to Decision 525 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code LDP — Colorimetry, Acetaminophen
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3030

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