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FDA 510(k)

DRUGS OF ABUSE CALIBRATOR

K-Number: K950139 · 1995-02-22

ApplicantE.I. Dupont DE Nemours & Co., Inc.
Decision Date1995-02-22
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRUGS OF ABUSE CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. It received FDA 510(k) clearance on 1995-02-22 under 510(k) number K950139. 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 CALIBRATOR?

DRUGS OF ABUSE CALIBRATOR is a medical device that received FDA 510(k) clearance on 1995-02-22. The listed applicant is E.I. Dupont DE Nemours & Co., Inc.. The 510(k) number is K950139.

When did DRUGS OF ABUSE CALIBRATOR receive FDA 510(k) clearance?

DRUGS OF ABUSE CALIBRATOR received FDA 510(k) clearance on 1995-02-22, under 510(k) number K950139.

Who is the listed applicant for DRUGS OF ABUSE CALIBRATOR?

The FDA 510(k) record lists E.I. Dupont DE Nemours & Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DRUGS OF ABUSE CALIBRATOR?

The FDA product code for DRUGS OF ABUSE CALIBRATOR is DKB.

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Other records listing E.I. Dupont DE Nemours & Co., 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.

K951851ALLIANCE CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN DIRECT IMMUNOFLUORESCENCE ASSAYK953724CRONEX RADIATION THERAPY CASSETTEK953725CRONEX RADIATION THERAPY VERIFICATION CASSETTEK951441DUPONT ACA DIGOXIN (DGN A) METHODK950137URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGEK950136URINE OPIATES SCREEN FLEX(TM) REAGENT CARTRIDGE

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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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