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FDA 510(k)

CHOLESTRON PRO II CHOLESTEROL TEST

K-Number: K981345 · 1998-10-01

ApplicantLifestream Diagnostics, Inc.
Decision Date1998-10-01
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTRON PRO II CHOLESTEROL TEST is the device name listed in this FDA 510(k) record. The listed applicant is Lifestream Diagnostics, Inc.. It received FDA 510(k) clearance on 1998-10-01 under 510(k) number K981345. 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 CHOLESTRON PRO II CHOLESTEROL TEST?

CHOLESTRON PRO II CHOLESTEROL TEST is a medical device that received FDA 510(k) clearance on 1998-10-01. The listed applicant is Lifestream Diagnostics, Inc.. The 510(k) number is K981345.

When did CHOLESTRON PRO II CHOLESTEROL TEST receive FDA 510(k) clearance?

CHOLESTRON PRO II CHOLESTEROL TEST received FDA 510(k) clearance on 1998-10-01, under 510(k) number K981345.

Who is the listed applicant for CHOLESTRON PRO II CHOLESTEROL TEST?

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

What is the FDA product code for CHOLESTRON PRO II CHOLESTEROL TEST?

The FDA product code for CHOLESTRON PRO II CHOLESTEROL TEST is CHH.

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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

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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