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FDA 510(k)

SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS

K-Number: K020769 · 2002-04-03

ApplicantLin-Zhi International, Inc.
Decision Date2002-04-03
Product CodeDLJ
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

SINGLE 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 2002-04-03 under 510(k) number K020769. The device is classified under product code DLJ. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS?

SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS is a medical device that received FDA 510(k) clearance on 2002-04-03. The listed applicant is Lin-Zhi International, Inc.. The 510(k) number is K020769.

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

SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS received FDA 510(k) clearance on 2002-04-03, under 510(k) number K020769.

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

The FDA product code for SINGLE ANALYTE URINE DRUGS OF ABUSE CALIBRATORS AND CONTROLS is DLJ.

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Related Devices (Code: DLJ)

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.

K132090BENZODIAZEPINE CALIBRATOR SET, BENZODIAZEPINE CONTROL LEVEL 1, AND BENZODIAZEPINE CONTROL LEVEL 2Randox Laboratories, Ltd.K091617QMS LIDOCAINE CALIBRATORS, MODEL 0374678Thermo Fisher ScientificK082030DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440Siemens Healthcare Diagnostics, Inc.K062182DIMENSION VISTA SYSTEM ECSTASY CALIBRATOR, MODEL KC520Dade Behring, Inc.K062199DIMENSION VISTA SYSTEM DRUG 3 CALIBRATOR (DRUG 3 CAL - KC430)Dade Behring, Inc.K061503DIMENSION CYCLOSPORINE EXTENDED RANGE CALIBRATOR (DC108A)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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