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FDA 510(k)

CENTRIFICHEM HDL CHOLESTEROL

K-Number: K801133 · 1980-06-17

ApplicantUnion Carbide Corp.
Decision Date1980-06-17
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

CENTRIFICHEM HDL 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 1980-06-17 under 510(k) number K801133. The device is classified under product code LBS. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CENTRIFICHEM HDL CHOLESTEROL?

CENTRIFICHEM HDL CHOLESTEROL is a medical device that received FDA 510(k) clearance on 1980-06-17. The listed applicant is Union Carbide Corp.. The 510(k) number is K801133.

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

CENTRIFICHEM HDL CHOLESTEROL received FDA 510(k) clearance on 1980-06-17, under 510(k) number K801133.

Who is the listed applicant for CENTRIFICHEM HDL 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 HDL CHOLESTEROL?

The FDA product code for CENTRIFICHEM HDL CHOLESTEROL is LBS.

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Other records listing Union Carbide Corp. as applicant

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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: LBS)

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.

K162593HDL-Cholesterol Gen.4Roche Diagnostics Operations (Rdo)K153435Direct HDL Cholesterol (HDL)Randox Laboratories, Ltd.K120609VITROS CHEMISTRY PRODUCTS DHDL SLIDESOrtho-Clinical Diagnostics, Inc.K111516NMR LIPOPROFILE (R) TEST AND NMR PROFILERLiposcience, Inc.K103747ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYSElitechgroup Seppim S.A.S.K111036EASYRA HDL REAGENT; EASYRA LDL REAGENT; EASYRA CHOL REAGENT; EASYRA TRIG REAGENTMedica Corporation

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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