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FDA 510(k)

DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS

K-Number: K983159 · 1998-11-05

ApplicantDiagnostic Reagents, Inc.
Decision Date1998-11-05
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Reagents, Inc.. It received FDA 510(k) clearance on 1998-11-05 under 510(k) number K983159. 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 DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS?

DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS is a medical device that received FDA 510(k) clearance on 1998-11-05. The listed applicant is Diagnostic Reagents, Inc.. The 510(k) number is K983159.

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

DRUGS OF ABUSE URINE CALIBRATORS AND CONTROLS received FDA 510(k) clearance on 1998-11-05, under 510(k) number K983159.

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

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

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

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

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Other records listing Diagnostic Reagents, Inc. as applicant

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.

K983268MODIFICATION OF TRICYCLIC SERUM TOX EIA ASSAYK983812NAPA EIA ASSAYK983323DIGOXIN IMMUNOASSAYK983280VANCOMYCIN EIA ASSAYK973102LIDOCAINE EIA ASSAYK97283550NG/ML COCAINE METABOLITE CALIBRATOR

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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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