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FDA 510(k)

RDI HOMOGENEOUS HDL CHOLESTEROL TEST

K-Number: K973988 · 1997-12-22

ApplicantReference Diagnostics, Inc.
Decision Date1997-12-22
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RDI HOMOGENEOUS HDL 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 1997-12-22 under 510(k) number K973988. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RDI HOMOGENEOUS HDL CHOLESTEROL TEST?

RDI HOMOGENEOUS HDL CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1997-12-22. The listed applicant is Reference Diagnostics, Inc.. The 510(k) number is K973988.

When did RDI HOMOGENEOUS HDL CHOLESTEROL TEST receive FDA 510(k) clearance?

RDI HOMOGENEOUS HDL CHOLESTEROL TEST received FDA 510(k) clearance on 1997-12-22, under 510(k) number K973988.

Who is the listed applicant for RDI HOMOGENEOUS HDL 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 HOMOGENEOUS HDL CHOLESTEROL TEST?

The FDA product code for RDI HOMOGENEOUS HDL CHOLESTEROL TEST is LBS.

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Other records listing Reference Diagnostics, Inc. as applicant

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K053291FERRITIN CALIBRATOR SET, CATALOG NO. 8203K053211RDI HSFERRITIN KITK052148TOTAL IRON-BINDING CAPACITY CALIBRATOR SET. DIRECT TIBC CALIBRATOR SETK030044EXTENDED RANGE HS CRP KIT, CAT NO:9200K030772RDI EXTENDED RANGE CRP CALIBRATOR SETK021609RDI HS CRP KIT

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Related Devices (Code: LBS)

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.

K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESOrtho-Clinical Diagnostics, Inc.K111516NMR LIPOPROFILE (R) TEST AND NMR PROFILERLiposcience, Inc.K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSElitechgroup Seppim S.A.S.K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTMedica Corporation

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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