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FDA 510(k)

HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B

K-Number: K041928 · 2004-11-23

ApplicantDiagnostic Chemicals , Ltd.
Decision Date2004-11-23
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B is the device name listed in this FDA 510(k) record. The listed applicant is Diagnostic Chemicals , Ltd.. It received FDA 510(k) clearance on 2004-11-23 under 510(k) number K041928. 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 HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B?

HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B is a medical device that received FDA 510(k) clearance on 2004-11-23. The listed applicant is Diagnostic Chemicals , Ltd.. The 510(k) number is K041928.

When did HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B receive FDA 510(k) clearance?

HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B received FDA 510(k) clearance on 2004-11-23, under 510(k) number K041928.

Who is the listed applicant for HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B?

The FDA 510(k) record lists Diagnostic Chemicals , Ltd. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B?

The FDA product code for HDL-ADVANCE ASSAY, CAT. NO. 278-20, 278-50A, 278-50B is LBS.

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Other records listing Diagnostic Chemicals , Ltd. as applicant

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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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