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FDA 510(k)

DIRECT HDL-CHOLESTEROL REAGENT

K-Number: K990581 · 1999-06-18

ApplicantKamiya Biomedical Co.
Decision Date1999-06-18
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

DIRECT HDL-CHOLESTEROL REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Kamiya Biomedical Co.. It received FDA 510(k) clearance on 1999-06-18 under 510(k) number K990581. 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 DIRECT HDL-CHOLESTEROL REAGENT?

DIRECT HDL-CHOLESTEROL REAGENT is a medical device that received FDA 510(k) clearance on 1999-06-18. The listed applicant is Kamiya Biomedical Co.. The 510(k) number is K990581.

When did DIRECT HDL-CHOLESTEROL REAGENT receive FDA 510(k) clearance?

DIRECT HDL-CHOLESTEROL REAGENT received FDA 510(k) clearance on 1999-06-18, under 510(k) number K990581.

Who is the listed applicant for DIRECT HDL-CHOLESTEROL REAGENT?

The FDA 510(k) record lists Kamiya Biomedical Co. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for DIRECT HDL-CHOLESTEROL REAGENT?

The FDA product code for DIRECT HDL-CHOLESTEROL REAGENT is LBS.

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Other records listing Kamiya Biomedical Co. as applicant

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K093137K-ASSAY CYSTATIN C REAGENT, CALIBRATOR AND CONTROLK091486K-ASSAY MICROALBUMIN AND K-ASSAY MICROALBUMIN CALIBRATORK050944K-ASSAY FERRITIN (2) & FERRITIN CALIBRATOR SETK042241K-ASSAY TOTAL IGE, K-ASSAY IGE CALIBRATOR SET, MODELS KAI-092/KAI-093CK030687K-ASSAY D-DIMER, K-ASSAY D-DIMER CALIBRATOR, MODELS KAI-090; KAJ-091CK023828K-ASSAY C-REACTIVE PROTEIN (3), K-ASSAY CRP MULTI-CALIBRATOR D, K-ASSAY CRP MULTI-CALIBRATOR E, K-ASSAY CRP MULTI-CALIBR

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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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