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FDA 510(k)

CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL

K-Number: K905296 · 1990-12-26

ApplicantCholestech Corp.
Decision Date1990-12-26
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Cholestech Corp.. It received FDA 510(k) clearance on 1990-12-26 under 510(k) number K905296. 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 CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL?

CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1990-12-26. The listed applicant is Cholestech Corp.. The 510(k) number is K905296.

When did CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL receive FDA 510(k) clearance?

CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL received FDA 510(k) clearance on 1990-12-26, under 510(k) number K905296.

Who is the listed applicant for CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL?

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

What is the FDA product code for CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL?

The FDA product code for CHOLESTECH LIPID MONITORING SYSTEM,HDL CHOLESTEROL is LBS.

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Other records listing Cholestech Corp. as applicant

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.

K040579CHOLETECH LDX HIGH-SENSITIVITY C-REACTIVE PROTEIN (HS-CRP)K032027CHOLESTECH LDX ASPARTATE AMINOTRANSFERASE (AST)K991834CHOLESTECH LDX ALANINE AMINOTRANSFERASE (ALT), MODEL 11-772K972012CHOLESTECH BUN/CREATININE TEST SYSTEMK954778CHOLESTECH LDX SYSTEMK946063TOTAL CHOLESTEROL AND HDL CHOLESTEROL PANEL

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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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