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FDA 510(k)

TINA-QUANT D-DIMER TEST SYSTEM

K-Number: K062203 · 2007-03-14

ApplicantRoche Diagnostics Corp.
Decision Date2007-03-14
Product CodeGHH
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

TINA-QUANT D-DIMER TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Corp.. It received FDA 510(k) clearance on 2007-03-14 under 510(k) number K062203. 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 TINA-QUANT D-DIMER TEST SYSTEM?

TINA-QUANT D-DIMER TEST SYSTEM is a medical device that received FDA 510(k) clearance on 2007-03-14. The listed applicant is Roche Diagnostics Corp.. The 510(k) number is K062203.

When did TINA-QUANT D-DIMER TEST SYSTEM receive FDA 510(k) clearance?

TINA-QUANT D-DIMER TEST SYSTEM received FDA 510(k) clearance on 2007-03-14, under 510(k) number K062203.

Who is the listed applicant for TINA-QUANT D-DIMER TEST SYSTEM?

The FDA 510(k) record lists Roche Diagnostics Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TINA-QUANT D-DIMER TEST SYSTEM?

The FDA product code for TINA-QUANT D-DIMER TEST SYSTEM is GHH.

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Other records listing Roche Diagnostics Corp. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K130138SUPER SANI-CLOTH/ ACCU-CHEK INFORM II SYSTEMK101365ELECSYS CA 19-9 CALCHECK 5K100853COBAS 8000 MODULAR SERIES ANALYZERK101196ACCU-CHEK ULTRFLEX INFUSION SETK093664AMPHETAMINES II ASSAYK101075ELECSYS INSULIN CALCHECK 5

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Related Devices (Code: GHH)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K112120DIAZYME D-DIMER ASSAY KIT,CALIBRATOR SETAND CONTROL SETDiazyme LaboratoriesK072288PATHFAST D-DIMERMitsubishi Kagaku IatronK070453OLYMPUS D-DIMER REAGENT, MODEL OSR6X135, OLYMPUS D-DIMER CALIBRATOR, MODEL ODR3033, OLYMPUS D-DIMER CONTROLOlympus Life & Material Science Europa GmbH (IrishK042890TRIAGE D-DIMER TEST, MODEL 98100Biosite IncorporatedK030740MODIFICATION TO TINA-QUANT D-DIMER TEST SYSTEMRoche Diagnostics Corp.K021877MDA D-DIMERbioMerieux, Inc.

Official Source

View on FDA Database →

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

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