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FDA 510(k)

RANDOX DIRECT LDL CHOLESTEROL

K-Number: K982529 · 1998-09-11

ApplicantRandox Laboratories, Ltd.
Decision Date1998-09-11
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RANDOX DIRECT LDL CHOLESTEROL 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 1998-09-11 under 510(k) number K982529. The device is classified under product code MRR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX DIRECT LDL CHOLESTEROL?

RANDOX DIRECT LDL CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1998-09-11. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K982529.

When did RANDOX DIRECT LDL CHOLESTEROL receive FDA 510(k) clearance?

RANDOX DIRECT LDL CHOLESTEROL received FDA 510(k) clearance on 1998-09-11, under 510(k) number K982529.

Who is the listed applicant for RANDOX DIRECT LDL CHOLESTEROL?

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 DIRECT LDL CHOLESTEROL?

The FDA product code for RANDOX DIRECT LDL CHOLESTEROL is MRR.

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Other records listing Randox Laboratories, Ltd. 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.

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: MRR)

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.

K241800Atellica® CH HDL Cholesterol (HDLC)& Atellica® CH LDL Cholesterol (LDLC)Siemens Healthcare Diagnostics, Inc.K210801AXINON® LDL-p Test SystemNumares AGK161691Direct LDL Cholesterol (LDL)Randox Laboratories LimitedK091333S-TEST LDL CHOLESTEROL (LDL), MODEL RC0022Alfa Wassermann, Inc.K090734EASYRA DLDL REAGENT, CALIBRATOR; EASYQC CHEMISTRY NO ELECTROLYTES, WITH ELECTROLYTESMedica Corp.K063841NMR PROFILER AND NMR LIPOPROFILE ASSAY, CONTROLSLiposcience

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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