ATAC PAK BUN REAGENT— 510(k) K021385

Substantially Equivalent

Elan Diagnostics

FDA 510(k) clearance K021385 for ATAC PAK BUN REAGENT, Substantially Equivalent on 2002-07-12. Applicant: Elan Diagnostics. Device class: 2.

Clearance details

Applicant: Elan Diagnostics
Product code: Code CDQ
Device class: Class 2
Regulation: 21 CFR 862.1770
Advisory panel: Clinical Chemistry
Date received: 2002-05-02
Decision date: 2002-07-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Brea, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Elan Diagnostics

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.