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FDA 510(k)

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems

K 號：K153651 · 2016-08-18

申請人Beckman Coulter, Inc.
決定日期2016-08-18
產品代碼JLW
諮詢委員會CH
決定Substantially Equivalent

器材摘要

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems is the device name listed in this FDA 510(k) record. The listed applicant is Beckman Coulter, Inc.. It received FDA 510(k) clearance on 2016-08-18 under 510(k) number K153651. The device is classified under product code JLW. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

常見問題

What is the Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems?

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems is a medical device that received FDA 510(k) clearance on 2016-08-18. The listed applicant is Beckman Coulter, Inc.. The 510(k) number is K153651.

When did Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems receive FDA 510(k) clearance?

Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems received FDA 510(k) clearance on 2016-08-18, under 510(k) number K153651.

Who is the listed applicant for Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems?

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

What is the FDA product code for Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems?

The FDA product code for Access TSH (3RD IS) Assay and Access TSH (3RD IS) Calibrators on the Access Immunoassay Systems is JLW.

相關臨床試驗

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其他以 Beckman Coulter, Inc. 為申請人之記錄

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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相關器械（代碼：JLW）

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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官方來源

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