VITROS CA 19-9— 510(k) K052889

Name: FDA 510(k) clearance K052889
Creator: U.S. Food and Drug Administration
Published: 2005-12-20

Substantially Equivalent

Fujirebio Diagnostics,Inc.

FDA 510(k) clearance K052889 for VITROS CA 19-9, Substantially Equivalent on 2005-12-20. Applicant: Fujirebio Diagnostics,Inc.. Device class: 2.

Clearance details

Applicant: Fujirebio Diagnostics,Inc.
Product code: Code NIG
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2005-10-13
Decision date: 2005-12-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Malvern, PA, US

Download summary PDF View on FDA.gov ↗

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K100375 — DIMENSION VISTA LOCI CA 19-9 FLEX REAGENT CARTRIDGE, AND DIMENSION LOCI7 CALIBRATOR WITH MODEL(S) K6457, AND KC6042011-04-06

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Adverse events under product code NIG

product code NIG

Malfunction: 618
Total: 618

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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