FDA 510(k)

IMMULITE 2000 TSI 测定，IMMULITE 2000 TSI 校准验证材料

K号: K152061 · 2016-03-03

决定日期2016-03-03

产品代码JZO

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决定实质等同

器械摘要

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material 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 2016-03-03 under 510(k) number K152061. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

常见问题

What is the IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material?

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material is a medical device that received FDA 510(k) clearance on 2016-03-03. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K152061.

When did IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material receive FDA 510(k) clearance?

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material received FDA 510(k) clearance on 2016-03-03, under 510(k) number K152061.

Who is the listed applicant for IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material?

FDA 510(k)记录中列出西门子医疗诊断公司（Siemens Healthcare Diagnostics, Inc.）为申请人。这本身并不足以确立该设备制造商的身份。

What is the FDA product code for IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material?

The FDA product code for IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material is JZO.

列明Siemens Healthcare Diagnostics, Inc.为申报人的其他记录

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