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FDA 510(k)

Tina-quant Lipoprotein(a) Gen.2 Molarity

K-Number: K241220 · 2025-01-24

ApplicantRoche Diagnostics Operations
Decision Date2025-01-24
Product CodeDFC
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

Tina-quant Lipoprotein(a) Gen.2 Molarity is the device name listed in this FDA 510(k) record. The listed applicant is Roche Diagnostics Operations. It received FDA 510(k) clearance on 2025-01-24 under 510(k) number K241220. 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 Tina-quant Lipoprotein(a) Gen.2 Molarity?

Tina-quant Lipoprotein(a) Gen.2 Molarity is a medical device that received FDA 510(k) clearance on 2025-01-24. The listed applicant is Roche Diagnostics Operations. The 510(k) number is K241220.

When did Tina-quant Lipoprotein(a) Gen.2 Molarity receive FDA 510(k) clearance?

Tina-quant Lipoprotein(a) Gen.2 Molarity received FDA 510(k) clearance on 2025-01-24, under 510(k) number K241220.

Who is the listed applicant for Tina-quant Lipoprotein(a) Gen.2 Molarity?

The FDA 510(k) record lists Roche Diagnostics Operations as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for Tina-quant Lipoprotein(a) Gen.2 Molarity?

The FDA product code for Tina-quant Lipoprotein(a) Gen.2 Molarity is DFC.

Other records listing Roche Diagnostics Operations 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.

K253069Lipoprotein (a) Molarity AssayDiazyme Laboratories, Inc.K211058Lp(a) UltraSENTINEL CH. SpAK180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc.

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.

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