ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033— 510(k) K111952

Name: FDA 510(k) clearance K111952
Creator: U.S. Food and Drug Administration
Published: 2011-08-19

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K111952 for ACCESS FOLATE CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS MODEL A98033, Substantially Equivalent on 2011-08-19. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code JIT
Device class: Class 2
Regulation: 21 CFR 862.1150
Advisory panel: Clinical Chemistry
Date received: 2011-07-11
Decision date: 2011-08-19
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K111952

K-number listed on FDA's recall record

Z-0047-2013 — Access Folate WHO Calibrators, Part Number: A98033. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay SystemsClass II·Terminated·Beckman Coulter Inc.·20120724

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K111952.

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