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FDA 510(k)

HDL CHOLESTEROL TEST KIT

K-Number: K801726 · 1980-09-09

ApplicantMallinckrodt Critical Care
Decision Date1980-09-09
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

HDL CHOLESTEROL TEST KIT is the device name listed in this FDA 510(k) record. The listed applicant is Mallinckrodt Critical Care. It received FDA 510(k) clearance on 1980-09-09 under 510(k) number K801726. 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 HDL CHOLESTEROL TEST KIT?

HDL CHOLESTEROL TEST KIT is a medical device that received FDA 510(k) clearance on 1980-09-09. The listed applicant is Mallinckrodt Critical Care. The 510(k) number is K801726.

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

HDL CHOLESTEROL TEST KIT received FDA 510(k) clearance on 1980-09-09, under 510(k) number K801726.

Who is the listed applicant for HDL CHOLESTEROL TEST KIT?

The FDA 510(k) record lists Mallinckrodt Critical Care as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for HDL CHOLESTEROL TEST KIT?

The FDA product code for HDL CHOLESTEROL TEST KIT is LBS.

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Other records listing Mallinckrodt Critical Care 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.

K880343BURNEY GALLBLADDER CATHETER KITK874605HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSORK874514HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBEK874568HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITORK873461LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)K874404HI-LO TEMP(R) SKIN TEMPERATURE SENSOR

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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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