FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020— 510(k) K052082

Name: FDA 510(k) clearance K052082
Creator: U.S. Food and Drug Administration
Published: 2005-08-19

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K052082 for FERRITIN ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 33020, Substantially Equivalent on 2005-08-19. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JMG
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 2005-08-02
Decision date: 2005-08-19
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K052082

K-number listed on FDA's recall record

Z-1833-2017 — Access Ferritin Calibrators, Part No. 33025, Ref No. B50136CClass II·Terminated·Beckman Coulter Inc.·20170310

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K052082.

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