CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT— 510(k) K132711

Name: FDA 510(k) clearance K132711
Creator: U.S. Food and Drug Administration
Published: 2014-05-08

Substantially Equivalent

Carolina Liquid Chemistries Corp.

FDA 510(k) clearance K132711 for CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT, Substantially Equivalent on 2014-05-08. Applicant: Carolina Liquid Chemistries Corp.. Device class: 1.

Clearance details

Applicant: Carolina Liquid Chemistries Corp.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 2013-08-29
Decision date: 2014-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Winston-Salem, NC, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code LBS

view all

K162593 — HDL-Cholesterol Gen.42016-10-19
K153435 — Direct HDL Cholesterol (HDL)2016-01-08
K120609 — VITROS CHEMISTRY PRODUCTS DHDL SLIDES2012-09-07
K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILER2011-09-27
K103747 — ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS2011-08-31

More clearances from Carolina Liquid Chemistries Corp.

view all

K213211 — Carolina Liquid Chemistries Cocaine and Cocaine Metabolite Enzyme Immunoassay (COCM) Test System2022-01-27
K133519 — CAROLINA LIQUID CHEMISTRIES CLC 6410 CHEMISTRY ANALYZER; CAROLINA LIQUID CHEMISTRIES GLUCOSE REAGENT, CAR2014-05-16
K971907 — CALCIUM REAGENT1997-06-24
K972073 — TOTAL BILIRUBIN REAGENT1997-06-24
K971324 — TRIGLYCERIDES, TG, OR TRIG1997-06-20

Data sourced from openFDA. This site is unofficial and independent of the FDA.