FDA 510(k)

Diazyme Lipoprotein (a) Assay

K-Number: K180074 · 2018-03-22

Decision Date2018-03-22

Product CodeDFC

Advisory CommitteeIM

DecisionSubstantially Equivalent

Device Summary

Diazyme Lipoprotein (a) Assay is a medical device manufactured by Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2018-03-22 under approval number K180074. The device is classified under product code DFC. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Diazyme Lipoprotein (a) Assay?

Diazyme Lipoprotein (a) Assay is a medical device that received FDA 510(k) clearance on 2018-03-22. It is manufactured by Diazyme Laboratories, Inc.. The 510(k) number is K180074.

When was Diazyme Lipoprotein (a) Assay approved by the FDA?

Diazyme Lipoprotein (a) Assay received FDA 510(k) clearance on 2018-03-22, under approval number K180074.

What company makes Diazyme Lipoprotein (a) Assay?

Diazyme Lipoprotein (a) Assay is manufactured by Diazyme Laboratories, Inc..

What is the FDA product code for Diazyme Lipoprotein (a) Assay?

The FDA product code for Diazyme Lipoprotein (a) Assay is DFC.

Other Devices by Diazyme Laboratories, Inc.

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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.