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FDA 510(k)

RDI DIRECT LDL CHOLESTEROL TEST

K-Number: K984107 · 1999-01-28

ApplicantReference Diagnostics, Inc.
Decision Date1999-01-28
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RDI DIRECT LDL CHOLESTEROL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Reference Diagnostics, Inc.. It received FDA 510(k) clearance on 1999-01-28 under 510(k) number K984107. 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 RDI DIRECT LDL CHOLESTEROL TEST?

RDI DIRECT LDL CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1999-01-28. The listed applicant is Reference Diagnostics, Inc.. The 510(k) number is K984107.

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

RDI DIRECT LDL CHOLESTEROL TEST received FDA 510(k) clearance on 1999-01-28, under 510(k) number K984107.

Who is the listed applicant for RDI DIRECT LDL CHOLESTEROL TEST?

The FDA 510(k) record lists Reference Diagnostics, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for RDI DIRECT LDL CHOLESTEROL TEST?

The FDA product code for RDI DIRECT LDL CHOLESTEROL TEST is MRR.

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Other records listing Reference Diagnostics, Inc. as applicant

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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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