FDA 510(k)

HDL

K-Number: K981580 · 1998-06-11

Decision Date1998-06-11

Product CodeLBS

Advisory CommitteeCH

DecisionSubstantially Equivalent

Device Summary

HDL is the device name listed in this FDA 510(k) record. The listed applicant is Abbott Laboratories. It received FDA 510(k) clearance on 1998-06-11 under 510(k) number K981580. 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?

HDL is a medical device that received FDA 510(k) clearance on 1998-06-11. The listed applicant is Abbott Laboratories. The 510(k) number is K981580.

When did HDL receive FDA 510(k) clearance?

HDL received FDA 510(k) clearance on 1998-06-11, under 510(k) number K981580.

Who is the listed applicant for HDL?

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

What is the FDA product code for HDL?

The FDA product code for HDL is LBS.

Other records listing Abbott Laboratories 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.

K262156Anti-HCV Next K252424Anti-HCV Next K243500ARCHITECT iGentamicin K243168Alinity i Rubella IgG K243283Alinity h-series System K233932Alinity i Toxo IgM

View all 876 devices →

Related Devices (Code: LBS)

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.