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FDA 510(k)

RESOLUTION CHOLESTEROL MONITOR

K-Number: K000610 · 2000-07-21

ApplicantLifestream Technologies, Inc.
Decision Date2000-07-21
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

RESOLUTION CHOLESTEROL MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Lifestream Technologies, Inc.. It received FDA 510(k) clearance on 2000-07-21 under 510(k) number K000610. 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 RESOLUTION CHOLESTEROL MONITOR?

RESOLUTION CHOLESTEROL MONITOR is a medical device that received FDA 510(k) clearance on 2000-07-21. The listed applicant is Lifestream Technologies, Inc.. The 510(k) number is K000610.

When did RESOLUTION CHOLESTEROL MONITOR receive FDA 510(k) clearance?

RESOLUTION CHOLESTEROL MONITOR received FDA 510(k) clearance on 2000-07-21, under 510(k) number K000610.

Who is the listed applicant for RESOLUTION CHOLESTEROL MONITOR?

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

What is the FDA product code for RESOLUTION CHOLESTEROL MONITOR?

The FDA product code for RESOLUTION CHOLESTEROL MONITOR is CHH.

Related Clinical Trials

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.

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Other records listing Lifestream Technologies, 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.

K033899LIFESTREAM PLUS CHOLESTEROL MONITOR, MODIFICATION TO RESOLUTION CHOLESTEROL MONITORK993096PRIVALINK SOFTWARE ACCESSORY TO THE LIFESTREAM CHOLESTEROL MONITOR

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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