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FDA 510(k)

MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

K-Number: K051088 · 2005-06-24

ApplicantLin-Zhi International, Inc.
Decision Date2005-06-24
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Lin-Zhi International, Inc.. It received FDA 510(k) clearance on 2005-06-24 under 510(k) number K051088. 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 MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS?

MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS is a medical device that received FDA 510(k) clearance on 2005-06-24. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K051088.

When did MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS receive FDA 510(k) clearance?

MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS received FDA 510(k) clearance on 2005-06-24, under 510(k) number K051088.

Who is the listed applicant for MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS?

The FDA 510(k) record lists Lin-Zhi International, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS?

The FDA product code for MULTIPLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS is DKB.

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Related Devices (Code: DKB)

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.

K120936ABBOTT TDM MULTICONSTITUENT CALIBRATOR, THERMO SCIENTIFIC QMS MULTI-CONSTITUENT CALIBRATORSMicrogenics CorporationK092266RANDOX 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 DiagnosticsK090900ADVIA CHEMISTRY DRUG CALIBRATOR II, MODEL 10376771Siemens Healthcare DiagnosticsK062162DIMENSION VISTA SYSTEM DRUGS OF ABUSE CALIBRATOR (UDAT CAL - KC510)Dade Behring, Inc.

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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