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FDA 510(k)

IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA

K-Number: K133124 · 2013-10-25

ApplicantSiemens Healthcare Diagnostics, Inc.
Decision Date2013-10-25
Product CodeJJX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA 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 2013-10-25 under 510(k) number K133124. The device is classified under product code JJX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA?

IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA is a medical device that received FDA 510(k) clearance on 2013-10-25. The listed applicant is Siemens Healthcare Diagnostics, Inc.. The 510(k) number is K133124.

When did IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA receive FDA 510(k) clearance?

IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA received FDA 510(k) clearance on 2013-10-25, under 510(k) number K133124.

Who is the listed applicant for IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA?

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; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA?

The FDA product code for IMMULITE 2000; TOTAL T3 CALIBRATION VERIFICATION MATERIAL, TOTAL T4 CALIBRATION VERIFICATION MATERIAL, TOTAL TBG CALIBRA is JJX.

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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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