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FDA 510(k)

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit

K-Number: K162705 · 2017-01-05

ApplicantMaine Standards Company, LLC
Decision Date2017-01-05
Product CodeGGN
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit is a medical device manufactured by Maine Standards Company, LLC. It received FDA 510(k) clearance on 2017-01-05 under approval number K162705. The device is classified under product code GGN. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit?

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit is a medical device that received FDA 510(k) clearance on 2017-01-05. It is manufactured by Maine Standards Company, LLC. The 510(k) number is K162705.

When was VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit approved by the FDA?

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit received FDA 510(k) clearance on 2017-01-05, under approval number K162705.

What company makes VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit?

VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit is manufactured by Maine Standards Company, LLC.

What is the FDA product code for VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit?

The FDA product code for VALIDATE® D-Dimer Calibration Verification/ Linearity Test Kit is GGN.

Related Clinical Trials

NCT07580651 Quality and Safety of Real-Time Brachytherapy Treatments: Clinical Implementation of a Multipoint Scintillation Detector for Treatment Monitoring NOT_YET_RECRUITING

Other Devices by Maine Standards Company, LLC

K152961VALIDATE D-Dimer Calibration Verification/Linearity Test Kit K170864VALIDATE D-Dimer Calibration Verification / Linearity Test Kit K163498VALIDATE Heparin Calibration Verification/Linearity Test Kit

Related Devices (Code: GGN)

K152961VALIDATE D-Dimer Calibration Verification/Linearity Test KitMaine Standards Company, LLC K150144VisuCon-F Low Fibrinogen Control PlasmaAffinity Biologicals, Inc. K170864VALIDATE D-Dimer Calibration Verification / Linearity Test KitMaine Standards Company, LLC K163498VALIDATE Heparin Calibration Verification/Linearity Test KitMaine Standards Company, LLC K161316George King Coumadin PlasmaGeorge King Bio-Medical, 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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