BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647— 510(k) K033036

Name: FDA 510(k) clearance K033036
Creator: U.S. Food and Drug Administration
Published: 2004-02-03

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K033036 for BR MONITOR AND BR MONITOR CALIBRATORS ON THE ACCESS IMMUNOASSAY SYSTEMS, MODEL 387620, 387647, Substantially Equivalent on 2004-02-03. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code MOI
Device class: Class 2
Regulation: 21 CFR 866.6010
Advisory panel: Immunology
Date received: 2003-09-29
Decision date: 2004-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

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Recalls naming K033036

K-number listed on FDA's recall record

Z-2074-2017 — Access BR Monitor, Part No. 387620Class II·Terminated·Beckman Coulter Inc.·20170413

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K033036.

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