FDA 510(k)

VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126

K-Number: K033879 · 2004-02-27

Decision Date2004-02-27

Product CodeDKB

Advisory CommitteeTX

DecisionSubstantially Equivalent

Device Summary

VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 is the device name listed in this FDA 510(k) record. The listed applicant is Maine Standards Co.. It received FDA 510(k) clearance on 2004-02-27 under 510(k) number K033879. The device is classified under product code DKB. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126?

VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 is a medical device that received FDA 510(k) clearance on 2004-02-27. The listed applicant is Maine Standards Co.. The 510(k) number is K033879.

When did VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 receive FDA 510(k) clearance?

VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 received FDA 510(k) clearance on 2004-02-27, under 510(k) number K033879.

Who is the listed applicant for VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126?

The FDA 510(k) record lists Maine Standards Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126?

The FDA product code for VALIDATE TDM CALIBRATION VERIFICATION TEST SET, MODEL 126 is DKB.

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Related Devices (Code: DKB)

K120936ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSMicrogenics Corporation K092266RANDOX METHAMPHETAMINE ASSAYRandox Laboratories, Ltd.K101752THERMO SCIENTIFIC CEDIA MULTI-DRUG OFT CALIBRATORSMicrogenics Corp.K090939ROCHE C.F.A.S. DAT QUALITATIVE PLUS CLINICAL CALIBRATOR AND CONTROL SET DAT CLINICAL, MODELS 04590856 190, 04500873 190Roche Diagnostics K090900ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771Siemens Healthcare Diagnostics K062162DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)Dade Behring, 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.