ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR— 510(k) K023407

Name: FDA 510(k) clearance K023407
Creator: U.S. Food and Drug Administration
Published: 2003-02-14

Substantially Equivalent

Elan Diagnostics

FDA 510(k) clearance K023407 for ATAC PAK CREATININE REAGENT AND ATAC CALIBRATOR, Substantially Equivalent on 2003-02-14. Applicant: Elan Diagnostics. Device class: 2.

Clearance details

Applicant: Elan Diagnostics
Product code: Code CGX
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2002-10-10
Decision date: 2003-02-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CGX

view all

K252206 — Nova Allegro UACR Assay, Nova Allegro Analyzer2026-01-09
K251058 — Tru Kidney Health Test Panel; Tru Analyzer2025-11-26
K242685 — Atellica® CH Creatinine_3 (Crea3)2024-12-04
K221813 — Nova Allegro UACR Assay, Nova Allegro Analyzer2024-11-19
K210452 — Creatinine22022-03-22

More clearances from Elan Diagnostics

view all

K030003 — ATAC DIRECT BILIRUBIN REAGENT AND CALIBRATOR2003-09-29
K030014 — ATAC TOTAL BILIRUBIN REAGENT2003-09-26
K030621 — ATAC CALIBRATOR2003-03-19
K023105 — ATAC CALCIUM REAGENT AND ATAC CALIBRATOR2003-03-13
K030010 — ATAC PAK MAGNESIUM REAGENT2003-03-10

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