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FDA 510(k)

IMMULITE 2000 第三代 TSH，IMMULITE 2000 自由 T4

K 號：K160647 · 2016-05-31

申請人Siemens Healthcare Diagnostics, Inc.
決定日期2016-05-31
產品代碼JLW
諮詢委員會CH
決定相當於

器材摘要

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-05-31 under 510(k) number K160647. 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 IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4?

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 is a medical device that received FDA 510(k) clearance on 2016-05-31. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K160647.

When did IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 receive FDA 510(k) clearance?

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 received FDA 510(k) clearance on 2016-05-31, under 510(k) number K160647.

Who is the listed applicant for IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4?

FDA 510(k) 記錄將西门子醫療診斷公司列為申請人。這並不單獨確立設備製造商。

What is the FDA product code for IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4?

The FDA product code for IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4 is JLW.

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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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