CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR— 510(k) K041627

Name: FDA 510(k) clearance K041627
Creator: U.S. Food and Drug Administration
Published: 2004-09-03

Substantially Equivalent

Dako A/S

FDA 510(k) clearance K041627 for CYSTATIN C IMMUNOPARTICLES, CONTROL SET, CALIBRATOR, Substantially Equivalent on 2004-09-03. Applicant: Dako A/S. Device class: 2.

Clearance details

Applicant: Dako A/S
Product code: Code NDY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2004-06-16
Decision date: 2004-09-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Glostrup, DK

Download summary PDF View on FDA.gov ↗

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