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FDA 510(k)

ACCUMETER HDL CHOLESTEROL TEST

K-Number: K943279 · 1995-05-01

ApplicantChemtrak, Inc.
Decision Date1995-05-01
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUMETER HDL CHOLESTEROL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Chemtrak, Inc.. It received FDA 510(k) clearance on 1995-05-01 under 510(k) number K943279. 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 ACCUMETER HDL CHOLESTEROL TEST?

ACCUMETER HDL CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1995-05-01. The listed applicant is Chemtrak, Inc.. The 510(k) number is K943279.

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

ACCUMETER HDL CHOLESTEROL TEST received FDA 510(k) clearance on 1995-05-01, under 510(k) number K943279.

Who is the listed applicant for ACCUMETER HDL CHOLESTEROL TEST?

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

What is the FDA product code for ACCUMETER HDL CHOLESTEROL TEST?

The FDA product code for ACCUMETER HDL CHOLESTEROL TEST is LBS.

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Other records listing Chemtrak, Inc. 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.

K972495ACCUMETER THEOPHYLLINE TESTK965099ACCUMETER H. PYLORI TESTK960478ACCUMETER H. PYLORI TESTK943599CHEM TRAK ACCUMETERK914432ACCUMETER(R) CHOLESTEROL SELF-TESTK905405CHEMTRAK ACCUMETER CHOLESTEROL TEST

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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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