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FDA 510(k)

RANDOX LIQUID PROTEIN CALIBRATOR

K-Number: K031608 · 2003-08-08

ApplicantRandox Laboratories, Ltd.
Decision Date2003-08-08
Product CodeJIX
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RANDOX LIQUID PROTEIN CALIBRATOR 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 2003-08-08 under 510(k) number K031608. The device is classified under product code JIX. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RANDOX LIQUID PROTEIN CALIBRATOR?

RANDOX LIQUID PROTEIN CALIBRATOR is a medical device that received FDA 510(k) clearance on 2003-08-08. The listed applicant is Randox Laboratories, Ltd.. The 510(k) number is K031608.

When did RANDOX LIQUID PROTEIN CALIBRATOR receive FDA 510(k) clearance?

RANDOX LIQUID PROTEIN CALIBRATOR received FDA 510(k) clearance on 2003-08-08, under 510(k) number K031608.

Who is the listed applicant for RANDOX LIQUID PROTEIN CALIBRATOR?

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 LIQUID PROTEIN CALIBRATOR?

The FDA product code for RANDOX LIQUID PROTEIN CALIBRATOR is JIX.

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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: JIX)

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.

K161140VITROS Chemistry Products Calibrator Kit 3Ortho-Clinical Diagnostics, Inc.K133330C.F.A.S. PROTEINS, C.F.A.S. PAC, PRECICONTROL CLINCHEM MULTI 1 & 2, PRECINORM PROTEIN & PRECIPATH PROTEINRoche DiagnosticsK130765ELITECH CLINICAL SYSTEMS ELICAL 2; ELITECH CLINICAL SYSTEMS ELITROL I, ELITECH CLINICAL SYSTEMS ELITROL IIElitechgroupK123321DIMENSION CHEMISTRY III CALIBRATORYSiemens Healthcare DiagnosticsK123372ABBOTT LIPID MULTI CONSTITUENT CALIBRATORAbbott LaboratoriesK122398RAPIDPOINT 500 SYSTEM MEASUREMENT CARTRIDGE WITH CALIBRATORSSiemens Healthcare 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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