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FDA 510(k)

Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set

K-Number: K143470 · 2016-01-31

ApplicantDiazyme Laboratories
Decision Date2016-01-31
Product CodeGIS
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set is a medical device manufactured by Diazyme Laboratories. It received FDA 510(k) clearance on 2016-01-31 under approval number K143470. The device is classified under product code GIS. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set?

Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set is a medical device that received FDA 510(k) clearance on 2016-01-31. It is manufactured by Diazyme Laboratories. The 510(k) number is K143470.

When was Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set approved by the FDA?

Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set received FDA 510(k) clearance on 2016-01-31, under approval number K143470.

What company makes Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set?

Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set is manufactured by Diazyme Laboratories.

What is the FDA product code for Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set?

The FDA product code for Diazyme Fibrinogen Assay, Diazyme Fibrinogen Calibrator Set, Diazyme Fibrinogen Control Set is GIS.

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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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