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FDA 510(k)

IMMULITE 2000 Third Generation TSH, IMMULITE 2000 Free T4

K-Number: K160647 · 2016-05-31

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2016-05-31
Product CodeJLW
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

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.

Frequently Asked Questions

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?

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

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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Related Devices (Code: JLW)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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