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FDA 510(k)

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set

K-Number: K161646 · 2016-11-04

ApplicantDiazyme Laboratories
Decision Date2016-11-04
Product CodeCGN
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is a medical device manufactured by Diazyme Laboratories. It received FDA 510(k) clearance on 2016-11-04 under approval number K161646. The device is classified under product code CGN. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is a medical device that received FDA 510(k) clearance on 2016-11-04. It is manufactured by Diazyme Laboratories. The 510(k) number is K161646.

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

Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set received FDA 510(k) clearance on 2016-11-04, under approval number K161646.

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

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

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

The FDA product code for Diazyme Folate Assay , Diazyme Folate Calibrator Set, Diazyme Folate Control Set is CGN.

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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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