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FDA 510(k)

RDI LIPIDIRECT MAGNETIC LDL REAGENT

K-Number: K964064 · 1996-11-20

ApplicantReference Diagnostics, Inc.
Decision Date1996-11-20
Product CodeMRR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RDI LIPIDIRECT MAGNETIC LDL REAGENT 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 1996-11-20 under 510(k) number K964064. 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 LIPIDIRECT MAGNETIC LDL REAGENT?

RDI LIPIDIRECT MAGNETIC LDL REAGENT is a medical device that received FDA 510(k) clearance on 1996-11-20. The listed applicant is Reference Diagnostics, Inc.. The 510(k) number is K964064.

When did RDI LIPIDIRECT MAGNETIC LDL REAGENT receive FDA 510(k) clearance?

RDI LIPIDIRECT MAGNETIC LDL REAGENT received FDA 510(k) clearance on 1996-11-20, under 510(k) number K964064.

Who is the listed applicant for RDI LIPIDIRECT MAGNETIC LDL REAGENT?

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 LIPIDIRECT MAGNETIC LDL REAGENT?

The FDA product code for RDI LIPIDIRECT MAGNETIC LDL REAGENT 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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