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FDA 510(k)

Lipoprotein (a) Molarity Assay

K-Number: K253069 · 2026-06-16

ApplicantDiazyme Laboratories, Inc.
Decision Date2026-06-16
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Lipoprotein (a) Molarity Assay is the device name listed in this FDA 510(k) record. The listed applicant is Diazyme Laboratories, Inc.. It received FDA 510(k) clearance on 2026-06-16 under 510(k) number K253069. 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 Lipoprotein (a) Molarity Assay?

Lipoprotein (a) Molarity Assay is a medical device that received FDA 510(k) clearance on 2026-06-16. The listed applicant is Diazyme Laboratories, Inc.. The 510(k) number is K253069.

When did Lipoprotein (a) Molarity Assay receive FDA 510(k) clearance?

Lipoprotein (a) Molarity Assay received FDA 510(k) clearance on 2026-06-16, under 510(k) number K253069.

Who is the listed applicant for Lipoprotein (a) Molarity Assay?

The FDA 510(k) record lists Diazyme Laboratories, Inc. as the applicant. This does not by itself establish the device manufacturer.

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

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

Other records listing Diazyme Laboratories, Inc. as applicant

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Related Devices (Code: DFC)

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.

K241220Tina-quant Lipoprotein(a) Gen.2 MolarityRoche Diagnostics OperationsK211058Lp(a) UltraSENTINEL CH. SpAK180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, 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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