GENTIAN CYSTATIN C IMMUNOASSAY— 510(k) K081875

Substantially Equivalent

Gentian AS

FDA 510(k) clearance K081875 for GENTIAN CYSTATIN C IMMUNOASSAY, Substantially Equivalent on 2008-08-20. Applicant: Gentian AS. Device class: 2.

Clearance details

Applicant: Gentian AS
Product code: Code NDY
Device class: Class 2
Regulation: 21 CFR 862.1225
Advisory panel: Clinical Chemistry
Date received: 2008-07-02
Decision date: 2008-08-20
Decision: Substantially Equivalent
Clearance type: Special
Location: San Diego, CA, US

Download summary PDF View on FDA.gov ↗

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More clearances from Gentian AS

K071388 — GENTIAN CYSTATIN C IMMUNOASSAY2007-11-06

Recalls naming K081875

K-number listed on FDA's recall record

Z-0099-2021 — GENTIAN Cystatin C Calibrator and Calibrator Kit, for the following models: 1. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 1012, UDI: (01)07090038460092 2. Gentian C E Calibrator Kit, 6 x 1 mL, REF 1051, UDI: (01)07090038460108 3. Gentian C E, BCI Ref: A52763, Cystatin C calibrator Kit, 6 x 1 mL, REF 1051, (01)17090038460037 4. Gentian C E, Cystatin C Calibrator, 1 x 1 mL, REF 8012 (Not distributed in US)Class II·Terminated·Gentian AS·20200902

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K081875.

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