FDA 510(k)

OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL

K-Number: K070453 · 2007-06-11

ApplicantOlympus Life & Material Science Europa GmbH (Irish

Decision Date2007-06-11

Product CodeGHH

Advisory CommitteeHE

DecisionSubstantially Equivalent

Device Summary

OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Olympus Life & Material Science Europa GmbH (Irish. It received FDA 510(k) clearance on 2007-06-11 under 510(k) number K070453. The device is classified under product code GHH. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL?

OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL is a medical device that received FDA 510(k) clearance on 2007-06-11. The listed applicant is Olympus Life & Material Science Europa GmbH (Irish. The 510(k) number is K070453.

When did OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL receive FDA 510(k) clearance?

OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL received FDA 510(k) clearance on 2007-06-11, under 510(k) number K070453.

Who is the listed applicant for OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL?

The FDA 510(k) record lists Olympus Life & Material Science Europa GmbH (Irish as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL?

The FDA product code for OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROL is GHH.

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Other records listing Olympus Life & Material Science Europa GmbH (Irish as applicant

K070708OLYMPUS FT4-FREE THYROXINE, OLYMPUS T4- TOTAL THYROXINE, MODEL# OSR210102, OSR210104 K070835OLYMPUS CK-MB REAGENT

Related Devices (Code: GHH)

K112120DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDiazyme Laboratories K072288PATHFAST D-DIMERMitsubishi Kagaku Iatron K062203TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.K042890TRIAGE D-DIMER TEST, MODEL 98100Biosite Incorporated K030740MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.K021877MDA D-DIMERbioMerieux, Inc.

Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.