Olympus Myoglobin Immunoturbidmetric Reagent

FDA 510(k) K984145 · Olympus Diagnostica GmbH

Substantially Equivalent

510(k) numberK984145

Submission

Device name
Olympus Myoglobin Immunoturbidmetric Reagent
Applicant
Olympus Diagnostica GmbH
Melville, NY, US
Received
November 19, 1998
Decision date
December 23, 1998
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
DDR – Myoglobin, Antigen, Antiserum, Control
Device class
Class II (moderate risk)
Regulation
21 CFR 866.5680
Specialty
Immunology

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K061683Tina-Quant Myoglobin GEN.2 Test SystemDDR · Traditional Roche Diagnostics Corp.07/21/2006SE
K042924Architect Stat Myo ImmunoassayDDR · Traditional Fisher Diagnostics01/24/2005SE
K042982Quantex MyoglobinDDR · Traditional Instrumentation Laboratory CO12/22/2004SE
K033300Vitros Immunodiagnostic Products Myoglobin Reagent Pack; Calibrators; Range VerifiersDDR · Traditional Ortho-Clinical Diagnostics, Inc.11/05/2003SE
K021229Myoglobin and Myoglobin Calibrators on the Access Immunoassay Systems, Model 973243…DDR · Traditional Beckman Coulter, Inc.06/28/2002SE

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Questions and answers

When was Olympus Myoglobin Immunoturbidmetric Reagent cleared by the FDA?

Olympus Myoglobin Immunoturbidmetric Reagent (K984145) received a 510(k) decision of Substantially Equivalent on December 23, 1998, 34 days after the submission was received.

What is the product code of K984145?

The FDA product code is DDR – Myoglobin, Antigen, Antiserum, Control, a Class II (moderate risk) device regulated under 21 CFR 866.5680.