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FDA 510(k)

PDC HDL EZ-SEP CHOLESTEROL REAGENT

K-Number: K840676 · 1984-04-04

ApplicantPreventive Diagnostics Corp.
Decision Date1984-04-04
Product CodeLBS
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

PDC HDL EZ-SEP CHOLESTEROL REAGENT is the device name listed in this FDA 510(k) record. The listed applicant is Preventive Diagnostics Corp.. It received FDA 510(k) clearance on 1984-04-04 under 510(k) number K840676. 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 PDC HDL EZ-SEP CHOLESTEROL REAGENT?

PDC HDL EZ-SEP CHOLESTEROL REAGENT is a medical device that received FDA 510(k) clearance on 1984-04-04. The listed applicant is Preventive Diagnostics Corp.. The 510(k) number is K840676.

When did PDC HDL EZ-SEP CHOLESTEROL REAGENT receive FDA 510(k) clearance?

PDC HDL EZ-SEP CHOLESTEROL REAGENT received FDA 510(k) clearance on 1984-04-04, under 510(k) number K840676.

Who is the listed applicant for PDC HDL EZ-SEP CHOLESTEROL REAGENT?

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

What is the FDA product code for PDC HDL EZ-SEP CHOLESTEROL REAGENT?

The FDA product code for PDC HDL EZ-SEP CHOLESTEROL REAGENT is LBS.

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Other records listing Preventive Diagnostics 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.

K840677HDL EZ-TZ3 CHOLESTEROL REAGENT KITK840278HDL CHOLESTEROL CONTROLS-LEVELSK840220HDL CHOLESTEROL AQUEOUS STANDARDSK840219TRIGLYCERIDE/CHOLESTEROL AQUEOUSK840968PRESERV TRANSPORT & CULTURE PACKK840189TOTAL CHOLESTEROL REAGENT SET

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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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