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FDA 510(k)

CHOLESTEROL TEST SYSTEM

K-Number: K850390 · 1985-07-09

ApplicantHans J. Brouwers & Assoc.
Decision Date1985-07-09
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL TEST SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Hans J. Brouwers & Assoc.. It received FDA 510(k) clearance on 1985-07-09 under 510(k) number K850390. 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 CHOLESTEROL TEST SYSTEM?

CHOLESTEROL TEST SYSTEM is a medical device that received FDA 510(k) clearance on 1985-07-09. The listed applicant is Hans J. Brouwers & Assoc.. The 510(k) number is K850390.

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

CHOLESTEROL TEST SYSTEM received FDA 510(k) clearance on 1985-07-09, under 510(k) number K850390.

Who is the listed applicant for CHOLESTEROL TEST SYSTEM?

The FDA 510(k) record lists Hans J. Brouwers & Assoc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CHOLESTEROL TEST SYSTEM?

The FDA product code for CHOLESTEROL TEST SYSTEM 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 Hans J. Brouwers & Assoc. 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.

K850391PLASMA EXTRACTION SYSTEM

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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