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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 a medical device manufactured by Roche Diagnostics Operations. It received FDA 510(k) clearance on 2025-01-24 under approval 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. It is manufactured by Roche Diagnostics Operations. The 510(k) number is K241220.

When was Tina-quant Lipoprotein(a) Gen.2 Molarity approved by the FDA?

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

What company makes Tina-quant Lipoprotein(a) Gen.2 Molarity?

Tina-quant Lipoprotein(a) Gen.2 Molarity is manufactured by Roche Diagnostics Operations.

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.

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Related Devices (Code: DFC)

K180074Diazyme Lipoprotein (a) AssayDiazyme Laboratories, Inc. K211058Lp(a) UltraSENTINEL CH. SpA

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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