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FDA 510(k)

CHOLESTEROL DETERMINATION

K-Number: K811760 · 1981-07-10

ApplicantBiorent Diagnostic, Inc.
Decision Date1981-07-10
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CHOLESTEROL DETERMINATION is the device name listed in this FDA 510(k) record. The listed applicant is Biorent Diagnostic, Inc.. It received FDA 510(k) clearance on 1981-07-10 under 510(k) number K811760. 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 DETERMINATION?

CHOLESTEROL DETERMINATION is a medical device that received FDA 510(k) clearance on 1981-07-10. The listed applicant is Biorent Diagnostic, Inc.. The 510(k) number is K811760.

When did CHOLESTEROL DETERMINATION receive FDA 510(k) clearance?

CHOLESTEROL DETERMINATION received FDA 510(k) clearance on 1981-07-10, under 510(k) number K811760.

Who is the listed applicant for CHOLESTEROL DETERMINATION?

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

What is the FDA product code for CHOLESTEROL DETERMINATION?

The FDA product code for CHOLESTEROL DETERMINATION is CHH.

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Other records listing Biorent Diagnostic, 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.

K832747ALBUMIN REAGENT SETK823060HEMOGLOBIN REAGENTK823211CK-UV REAGENTK822493OPTIMIZED UV-GOT REAGENT SETK822494OPTIMIZED UV-GPT REAGENT SETK822492OPTIMIZED UV-LDH REAGENT SET

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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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