FDA 510(k)

Tina-quant 脂蛋白(a) Gen.2 摩尔浓度

K号: K241220 · 2025-01-24

决定日期2025-01-24

产品代码DFC

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决定实质等同

器械摘要

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.

常见问题

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.

列明Roche Diagnostics Operations为申报人的其他记录

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