FDA 510(k)

CoLink PCR植板系統

K 號：K213698 · 2022-05-27

決定日期2022-05-27

產品代碼HRS

諮詢委員會或

決定相當於

器材摘要

CoLink PCR Plating System is the device name listed in this FDA 510(k) record. The listed applicant is In2bones USA, LLC. It received FDA 510(k) clearance on 2022-05-27 under 510(k) number K213698. The device is classified under product code HRS. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the CoLink PCR Plating System?

CoLink PCR Plating System is a medical device that received FDA 510(k) clearance on 2022-05-27. The listed applicant is In2bones USA, LLC. The 510(k) number is K213698.

When did CoLink PCR Plating System receive FDA 510(k) clearance?

CoLink PCR Plating System received FDA 510(k) clearance on 2022-05-27, under 510(k) number K213698.

Who is the listed applicant for CoLink PCR Plating System?

The FDA 510(k) record lists In2bones USA, LLC as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CoLink PCR Plating System?

The FDA product code for CoLink PCR Plating System is HRS.

其他以 In2bones USA, LLC 為申請人之記錄

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相關器械（代碼：HRS）

相關紀錄係使用名稱、產品代碼或其他後設資料自動配對。配對結果並不構成已驗證的臨床、科學、企業或監管關係，請查閱連結的官方來源。

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