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Gentian Cystatin C Immunoassay

by Gentian AS Norway 510(k)

510(k) K071388 Product code NDY

Regulatory status

as of 26 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK071388 Date6 Nov 2007ClearedStatusActive

Coverage

1 jurisdiction

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  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not known
  • Not covered

United States — FDA 510(k) Active

Recalls

1 recall · FDA

    • Terminated Z-0099-2021 FDA Class II initiated 2 Sep 2020

    The firm has identified lots of calibrators that have shown to measure incorrect high values over time compared to the assigned values when released for distribution. This could result in higher Cystatin C values measured in patients.

Specification

510(k) · synced 10 Oct 2026

510(k) Number
FDA Product Code
NDY
Device Class
Class II
Regulation
21 CFR Part 862.1225
Advisory Committee
Clinical Chemistry
FDA Decision
SESE Substantially Equivalent

Other devices from Gentian AS

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Properties & raw data

Show properties, registry sources and raw records

Sources (1)

  • FDA 510(k) K071388 24 fields · synced 10 Oct 2026