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FDA 510(k)

ACCUMETER(R) CHOLESTEROL SELF-TEST

K-Number: K914432 · 1993-03-02

ApplicantChemtrak, Inc.
Decision Date1993-03-02
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ACCUMETER(R) CHOLESTEROL SELF-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 1993-03-02 under 510(k) number K914432. The device is classified under product code CHH. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUMETER(R) CHOLESTEROL SELF-TEST?

ACCUMETER(R) CHOLESTEROL SELF-TEST is a medical device that received FDA 510(k) clearance on 1993-03-02. The listed applicant is Chemtrak, Inc.. The 510(k) number is K914432.

When did ACCUMETER(R) CHOLESTEROL SELF-TEST receive FDA 510(k) clearance?

ACCUMETER(R) CHOLESTEROL SELF-TEST received FDA 510(k) clearance on 1993-03-02, under 510(k) number K914432.

Who is the listed applicant for ACCUMETER(R) CHOLESTEROL SELF-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(R) CHOLESTEROL SELF-TEST?

The FDA product code for ACCUMETER(R) CHOLESTEROL SELF-TEST is CHH.

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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 TESTK943279ACCUMETER HDL CHOLESTEROL TESTK943599CHEM TRAK ACCUMETERK905405CHEMTRAK ACCUMETER CHOLESTEROL TEST

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Related Devices (Code: CHH)

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.

K251091LipidsTruvian HealthK232404CHOLESTEROL; HDL-cholesterol ; LDL-cholesterol; TRIGLYCERIDESMedicon Hellas S.AK203597Cholesterol2Abbott Ireland Diagnostics DivisionK190490VITROS XT Chemistry Products TRIG-CHOL SlidesOrtho-Clinical Diagnostics, Inc.K181373Extended Lipid Panel AssayLaboratory Corporation of America HoldingsK180504Mission Lipid Panel Monitoring SystemACON Laboratories, Inc.

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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