FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208— 510(k) K060774

Name: FDA 510(k) clearance K060774
Creator: U.S. Food and Drug Administration
Published: 2006-04-21

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K060774 for FOLATE ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL A14208, Substantially Equivalent on 2006-04-21. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code CGN
Device class: Class 2
Regulation: 21 CFR 862.1295
Advisory panel: Clinical Chemistry
Date received: 2006-03-22
Decision date: 2006-04-21
Decision: Substantially Equivalent
Clearance type: Special
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K060774

K-number listed on FDA's recall record

Z-0046-2013 — Access Folate Calibrators, Part Number: A14207. The Access Folate assay is a paramagnetic particle, chemiluminescent immunoassay for the quantitative determination of folic acid levels in human serum, plasma (heparin) or red blood cells using the Access Immunoassay Systems. The serum folate level is an indicator of recent folate intake. A low RBC folate value can indicate a prolonged folate deficiency. The Access Folate Calibrators are intended to calibrate the Access Folate assay using the Access Immunoassay Systems.Class 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 K060774.

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