AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10— 510(k) K033921

Name: FDA 510(k) clearance K033921
Creator: U.S. Food and Drug Administration
Published: 2004-03-10

Substantially Equivalent

Diagnostic Chemicals , Ltd.

FDA 510(k) clearance K033921 for AMMONIA-L3K ASSAY, CATALOGUE NUMBER 233-10, Substantially Equivalent on 2004-03-10. Applicant: Diagnostic Chemicals , Ltd.. Device class: 1.

Clearance details

Applicant: Diagnostic Chemicals , Ltd.
Product code: Code JIF
Device class: Class 1
Regulation: 21 CFR 862.1065
Advisory panel: Clinical Chemistry
Date received: 2003-12-18
Decision date: 2004-03-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Charlottetown, P.E., CA

Download summary PDF View on FDA.gov ↗

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Recalls naming K033921

K-number listed on FDA's recall record

Z-1078-2017 — Sekisui Diagnostics Ammonia L3K¿ Assay; Catalog Number: 293-80-91 and 293-10 For the IN VITRO quantitative measurement of ammonia concentration in plasmaClass II·Terminated·Sekisui Diagnostics P.E.I. Inc.·20161129

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033921.

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