FDA 510(k)

DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A

K-Number: K100778 · 2010-05-05

Decision Date2010-05-05

Product CodeJIX

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Healthcare Diagnostics. It received FDA 510(k) clearance on 2010-05-05 under 510(k) number K100778. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A?

DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A is a medical device that received FDA 510(k) clearance on 2010-05-05. The listed applicant is Siemens Healthcare Diagnostics. The 510(k) number is K100778.

When did DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A receive FDA 510(k) clearance?

DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A received FDA 510(k) clearance on 2010-05-05, under 510(k) number K100778.

Who is the listed applicant for DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A?

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

What is the FDA product code for DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A?

The FDA product code for DIMENSION EXL LOCI THYROID CALIBRATOR, MODEL RC 610A is JIX.

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Related Devices (Code: JIX)

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Official Source

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