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FDA 510(k)

RANDOX HUMAN ASSSAYED DRUG CONTROL

K-Number: K012319 · 2001-08-24

ApplicantRandox Laboratories, Ltd.
Decision Date2001-08-24
Product CodeDIF
Advisory CommitteeTX
DecisionSubstantially Equivalent

Device Summary

RANDOX HUMAN ASSSAYED DRUG CONTROL is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories, Ltd.. It received FDA 510(k) clearance on 2001-08-24 under 510(k) number K012319. The device is classified under product code DIF. It was reviewed by the TX advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX HUMAN ASSSAYED DRUG CONTROL?

RANDOX HUMAN ASSSAYED DRUG CONTROL is a medical device that received FDA 510(k) clearance on 2001-08-24. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K012319.

When did RANDOX HUMAN ASSSAYED DRUG CONTROL receive FDA 510(k) clearance?

RANDOX HUMAN ASSSAYED DRUG CONTROL received FDA 510(k) clearance on 2001-08-24, under 510(k) number K012319.

Who is the listed applicant for RANDOX HUMAN ASSSAYED DRUG CONTROL?

The FDA 510(k) record lists Randox Laboratories, Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RANDOX HUMAN ASSSAYED DRUG CONTROL?

The FDA product code for RANDOX HUMAN ASSSAYED DRUG CONTROL is DIF.

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Other records listing Randox Laboratories, Ltd. as applicant

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K230890ISE ElectrodesK182042Randox Calcium (Ca)K162200Randox RX Daytona Plus Magnesium (MG)K152085Liquid CO2-2 (LCO2-2)K153435Direct HDL Cholesterol (HDL)K123977RANDOX LIQUID CK-MB, RANDOX CK-MB CALIBRATOR

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Related Devices (Code: DIF)

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.

K153474Detectabuse Liquid Control Urine, Detectabuse Stat-Skreen Liquid Control Urine, Detectabuse Liquid Control Urine, AU/NZ, Detectabuse Liquid Control Urine, Immunoassay Series, Detectabuse Liquid Control Urine, GC/MS and Confirm seriesBiochemical Diagnostics, Inc.K132688SALIVABUSE LIQUID ORAL FLUID CONTROL, SALIVABUSE LIQUID ORAL FLUID CONTROL, AU/NZBiochemical Diagnostics, Inc.K132174MULTICHEM WBTTechno-Path Manufacturing , Ltd.K121122DETECTABUSE LIQUID CONTROL, DETECTABUSE STAT-SKREEN LIQUID CONTROLBiochemical Diagnostic, Inc.K121143LIQUICHEK WHOLE BLOOD IMMUNOSUPPRESSANT CONTROL TILEVEL (1,2 AND 3)Bio-Rad LaboratoriesK120504LIQUICHEK URINE TOXICOLOGY CONTROL, S10 & S10 MINIPAK, LIQUICHEK URINE TOXICOLOGY CONTROL, LEVEL S20 & LEVEL S20 MINIPAKBio-Rad Laboratories, 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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