FDA 510(k)

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)

K-Number: K032697 · 2003-11-07

Decision Date2003-11-07

Product CodeJIS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) is the device name listed in this FDA 510(k) record. The listed applicant is Dade Behring, Inc.. It received FDA 510(k) clearance on 2003-11-07 under 510(k) number K032697. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)?

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) is a medical device that received FDA 510(k) clearance on 2003-11-07. The listed applicant is Dade Behring, Inc.. The 510(k) number is K032697.

When did DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) receive FDA 510(k) clearance?

DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) received FDA 510(k) clearance on 2003-11-07, under 510(k) number K032697.

Who is the listed applicant for DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)?

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

What is the FDA product code for DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)?

The FDA product code for DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414) is JIS.

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Other records listing Dade Behring, Inc. as applicant

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Related Devices (Code: JIS)

K122126DIRECT LDL/HDL CHOLESTEROL CALIBRATORRandox Laboratories Limited K061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MB K032296VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORSOrtho-Clinical Diagnostics, Inc.

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.