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FDA 510(k)

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR

K-Number: K122126 · 2012-08-14

ApplicantRandox Laboratories Limited
Decision Date2012-08-14
Product CodeJIS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR is the device name listed in this FDA 510(k) record. The listed applicant is Randox Laboratories Limited. It received FDA 510(k) clearance on 2012-08-14 under 510(k) number K122126. The device is classified under product code JIS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DIRECT LDL/HDL CHOLESTEROL CALIBRATOR?

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR is a medical device that received FDA 510(k) clearance on 2012-08-14. The listed applicant is Randox Laboratories Limited. The 510(k) number is K122126.

When did DIRECT LDL/HDL CHOLESTEROL CALIBRATOR receive FDA 510(k) clearance?

DIRECT LDL/HDL CHOLESTEROL CALIBRATOR received FDA 510(k) clearance on 2012-08-14, under 510(k) number K122126.

Who is the listed applicant for DIRECT LDL/HDL CHOLESTEROL CALIBRATOR?

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

What is the FDA product code for DIRECT LDL/HDL CHOLESTEROL CALIBRATOR?

The FDA product code for DIRECT LDL/HDL CHOLESTEROL CALIBRATOR is JIS.

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Other records listing Randox Laboratories Limited as applicant

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Related Devices (Code: JIS)

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.

K061251DIMENSION VISTA TOTAL IRON BINDING CAPACITY CALIBRATORDade Behring, Inc.K060266DIMENSION IRON CALIBRATORDade Behring, Inc.K053104DIMENSION CARDIOPHASE HIGH SENSITIVITY C-REACTIVE PROTEIN CALIBRATORDade Behring, Inc.K032697DIMENSION TOTAL TRIIODOTHYRONINE CALIBRATOR (RC414)Dade Behring, Inc.K032608GONOTEC CALIBRATION SOLUTION 300 MOSMOL/KG FOR OSMOMETERGonotec Gesellschaft Fuer Mess-Und Regeltechnik MBK032296VITROS IMMUNODIAGNOSTIC PRODUCTS PROGESTRONE REAGENT PACK AND CALIBRATORSOrtho-Clinical Diagnostics, 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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