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FDA 510(k)

DRUGS OF ABUSE URINE CALIBRATORS

K-Number: K892332 · 1989-05-11

ApplicantHycor Biomedical, Inc.
Decision Date1989-05-11
Product CodeDKB
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

DRUGS OF ABUSE URINE CALIBRATORS is the device name listed in this FDA 510(k) record. The listed applicant is Hycor Biomedical, Inc.. It received FDA 510(k) clearance on 1989-05-11 under 510(k) number K892332. 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?

DRUGS OF ABUSE URINE CALIBRATORS is a medical device that received FDA 510(k) clearance on 1989-05-11. The listed applicant is Hycor Biomedical, Inc.. The 510(k) number is K892332.

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

DRUGS OF ABUSE URINE CALIBRATORS received FDA 510(k) clearance on 1989-05-11, under 510(k) number K892332.

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

The FDA 510(k) record lists Hycor Biomedical, 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?

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

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Other records listing Hycor Biomedical, Inc. as applicant

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K081217HY-TEC SPECIFIC AND TOTAL IGE EIA SYSTEMK080322HY*TEC EXTENDED SPECIFIC IGE EIA, MCS ASSAY USING TECAN FREEDOM EVO RSP 200K022944AUTOSTAT II ANTI-B-2 GLYCOPROTEIN-I IGM ELISAK022945AUTOSTAT II ANTI-B-2 GLYCOPROTEIN I IGG ELISAK965094HYCOR ALLERGEN DISCK962728HYCOR HY.TEC/MANUAL ENA AUTO-ANTIBODY

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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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