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FDA 510(k)

CHOLESTECH LDX SYSTEM

K-Number: K954778 · 1995-11-24

ApplicantCholestech Corp.
Decision Date1995-11-24
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTECH LDX SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Cholestech Corp.. It received FDA 510(k) clearance on 1995-11-24 under 510(k) number K954778. 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 LDX SYSTEM?

CHOLESTECH LDX SYSTEM is a medical device that received FDA 510(k) clearance on 1995-11-24. The listed applicant is Cholestech Corp.. The 510(k) number is K954778.

When did CHOLESTECH LDX SYSTEM receive FDA 510(k) clearance?

CHOLESTECH LDX SYSTEM received FDA 510(k) clearance on 1995-11-24, under 510(k) number K954778.

Who is the listed applicant for CHOLESTECH LDX SYSTEM?

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 LDX SYSTEM?

The FDA product code for CHOLESTECH LDX SYSTEM 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 SYSTEMK946064TOTAL CHOLESTEROL CASSETTEK946063TOTAL 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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