ACCESS FERRITIN ASSAY— 510(k) K926221

Name: FDA 510(k) clearance K926221
Creator: U.S. Food and Drug Administration
Published: 1993-01-13

Substantially Equivalent

Bio-Rad Laboratories, Inc.

FDA 510(k) clearance K926221 for ACCESS FERRITIN ASSAY, Substantially Equivalent on 1993-01-13. Applicant: Bio-Rad Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Bio-Rad Laboratories, Inc.
Product code: Code JMG
Device class: Class 2
Regulation: 21 CFR 866.5340
Advisory panel: Immunology
Date received: 1992-12-10
Decision date: 1993-01-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K926221

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 K926221.

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