AXIOM STABLE II TRIGLYCERIDES TEST— 510(k) K842443

Substantially Equivalent

Axiom, Inc.

FDA 510(k) clearance K842443 for AXIOM STABLE II TRIGLYCERIDES TEST, Substantially Equivalent on 1984-09-13. Applicant: Axiom, Inc.. Device class: 1.

Clearance details

Applicant: Axiom, Inc.
Product code: Code CDT
Device class: Class 1
Regulation: 21 CFR 862.1705
Advisory panel: Clinical Chemistry
Date received: 1984-06-21
Decision date: 1984-09-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CDT

K150819 — Triglycerides2015-08-06
K133067 — ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT2013-11-22
K130332 — VITROS CHEMISTRY PRODUCTS TRIG SLIDES2013-05-31
K113830 — VANTERA CLINICAL ANALYZER2012-08-30
K102993 — ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL2011-05-19

More clearances from Axiom, Inc.

K883887 — AXIOM ATRAUM WOUND DRAINS1989-02-17
K842442 — AXIOM STABLE II URIC ACID TEST1984-08-16
K842441 — AXIOM STABLE II CHOLESTEROL TEST1984-07-25

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