ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS— 510(k) K080481

Name: FDA 510(k) clearance K080481
Creator: U.S. Food and Drug Administration
Published: 2009-02-20

Substantially Equivalent

Beckman Coulter, Inc.

FDA 510(k) clearance K080481 for ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN AND ACCESS IMMUNOASSAY SYSTEMS MYOGLOBIN CALIBRATORS, Substantially Equivalent on 2009-02-20. Applicant: Beckman Coulter, Inc.. Device class: 2.

Clearance details

Applicant: Beckman Coulter, Inc.
Product code: Code DDR
Device class: Class 2
Regulation: 21 CFR 866.5680
Advisory panel: Immunology
Date received: 2008-02-22
Decision date: 2009-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chaska, MN, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code DDR

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K231832 — Access Myoglobin2023-09-18
K123785 — DIAZYME MYOGLOBIN; ASSAY, CALIBRATOR SET, CONTROL SET2013-06-07
K122599 — ADVIA CHEMISTRY MYOGLOBIN REAGENT, ADVIA CHEMISTRY MYOGLBIN CALIBRATOR2012-10-03
K083260 — ELECSYS MYOGLOBIN STAT, AND ELECSYS MYOGLOBIN2009-10-16
K061683 — TINA-QUANT MYOGLOBIN GEN.2 TEST SYSTEM2006-07-21

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