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FDA 510(k)

CENTRIFICHEM CHOLESTEROL

K-Number: K800765 · 1980-04-24

ApplicantUnion Carbide Corp.
Decision Date1980-04-24
Product CodeCHH
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIFICHEM CHOLESTEROL is the device name listed in this FDA 510(k) record. The listed applicant is Union Carbide Corp.. It received FDA 510(k) clearance on 1980-04-24 under 510(k) number K800765. 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 CENTRIFICHEM CHOLESTEROL?

CENTRIFICHEM CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1980-04-24. The listed applicant is Union Carbide Corp.. The 510(k) number is K800765.

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

CENTRIFICHEM CHOLESTEROL received FDA 510(k) clearance on 1980-04-24, under 510(k) number K800765.

Who is the listed applicant for CENTRIFICHEM CHOLESTEROL?

The FDA 510(k) record lists Union Carbide Corp. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for CENTRIFICHEM CHOLESTEROL?

The FDA product code for CENTRIFICHEM CHOLESTEROL is CHH.

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Other records listing Union Carbide Corp. 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.

K830337MARK III OXYGEN WALKER SYS-LOW PRESSK820836MARK III OXYGEN WALKER SYSTEMK820535LASER GAS MIXTURESK812536LINDE MARK IIK810732LINDE MARK II OXYGEN RESERV. TYPE OR-4K810596CENTRIFI CHEM SYSTEM 400 ANALYZER

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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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