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FDA 510(k)

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material

K-Number: K152061 · 2016-03-03

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2016-03-03
Product CodeJZO
Advisory CommitteeIM
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material is a medical device manufactured by Siemens Healthcare Diagnostics, Inc.. It received FDA 510(k) clearance on 2016-03-03 under approval number K152061. The device is classified under product code JZO. It was reviewed by the IM advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

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. It is manufactured by Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K152061.

When was IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material approved by the FDA?

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

What company makes IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material?

IMMULITE 2000 TSI Assay, IMMULITE 2000 TSI Calibration Verification Material is manufactured by Siemens Healthcare Diagnostics, Inc..

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.

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Related PubMed Literature

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Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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