510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K081938Substantially Equivalent

Acetaminophen L3k Assay, and Acetaminophen L3k Assay, Models 506-10, 506-30

Genzyme Diagnostics P.E.I., Inc., Charlottetown, Prin Ed Island, CA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K081938 is the FDA 510(k) clearance record for ACETAMINOPHEN L3K ASSAY, AND ACETAMINOPHEN L3K ASSAY, MODELS 506-10, 506-30, a class II device, cleared for Genzyme Diagnostics P.E.I., Inc. on under FDA product code LDP (Colorimetry, Acetaminophen). FDA records list 2 510(k) clearances for Genzyme Diagnostics P.E.I., Inc., from to . As of , FDA records show 2 recalls naming K081938.

Clearance record

Decision date
Received
(297 days to decision)
Product code
LDP Colorimetry, Acetaminophen
Regulation
21 CFR 862.3030
Device class
Class II
Review panel
Clinical Toxicology
Applicant
Genzyme Diagnostics P.E.I., Inc. 700 Watts Ave., Charlottetown, Prin Ed Island, CA
510(k) summary
Summary PDF
Third party review
No

Clearances, product code LDP

Trailing 12 months
1 clearance under product code LDP in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code LDP, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20260
October 20260