Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS

K-Number: K013662 · 2002-03-08

ApplicantQuantimetrix Corp.
Decision Date2002-03-08
Product CodeJHO
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS is the device name listed in this FDA 510(k) record. The listed applicant is Quantimetrix Corp.. It received FDA 510(k) clearance on 2002-03-08 under 510(k) number K013662. The device is classified under product code JHO. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS?

MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS is a medical device that received FDA 510(k) clearance on 2002-03-08. The listed applicant is Quantimetrix Corp.. The 510(k) number is K013662.

When did MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS receive FDA 510(k) clearance?

MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS received FDA 510(k) clearance on 2002-03-08, under 510(k) number K013662.

Who is the listed applicant for MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS?

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

What is the FDA product code for MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS?

The FDA product code for MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS is JHO.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Quantimetrix 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.

K113177COMPLETE D 25-OH VITAMIN D CONTROLK103744DROPPER A1C DIABETES CONTROLK062942QUANTIMETRIX NICOSURE COTININE URINE CONTROLK062751MODIFICATION TO QUANTIMETRIX CARDIASURE CARDIAC MARKERK060417MODIFICATION TO QUANTIMETRIX URINE DRUGS OF ABUSE CONTROLK032791GLYCOHEMOSURE HBA1C CONTROL

View all 37 devices →

Related Devices (Code: JHO)

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.

K022333SPIFE LIPPOROTEIN-12, MODEL 3344Helena LaboratoriesK022053HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134SebiaK012789MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123MoraxK013466SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343Helena LaboratoriesK010337LIPOPRINT SYSTEM, LDL SUBFRACTIONSQuantimetrix Corp.K000603SPIFE CHOLESTEROL PROFILE KITHelena Laboratories

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.

↑