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FDA 510(k)

CHEMTRAK ACCUMETER CHOLESTEROL TEST

K-Number: K905405 · 1991-03-19

ApplicantChemtrak, Inc.
Decision Date1991-03-19
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHEMTRAK ACCUMETER 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 1991-03-19 under 510(k) number K905405. 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 CHEMTRAK ACCUMETER CHOLESTEROL TEST?

CHEMTRAK ACCUMETER CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1991-03-19. The listed applicant is Chemtrak, Inc.. The 510(k) number is K905405.

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

CHEMTRAK ACCUMETER CHOLESTEROL TEST received FDA 510(k) clearance on 1991-03-19, under 510(k) number K905405.

Who is the listed applicant for CHEMTRAK ACCUMETER 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 CHEMTRAK ACCUMETER CHOLESTEROL TEST?

The FDA product code for CHEMTRAK ACCUMETER CHOLESTEROL 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 ACCUMETERK914432ACCUMETER(R) CHOLESTEROL SELF-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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