N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR— 510(k) K971190

Name: FDA 510(k) clearance K971190
Creator: U.S. Food and Drug Administration
Published: 1997-06-16

Substantially Equivalent

Genzyme Corp.

FDA 510(k) clearance K971190 for N-GENEOUS HDL CHOLESTEROL KIT/CHOLESTEROL CALIBRATOR, Substantially Equivalent on 1997-06-16. Applicant: Genzyme Corp.. Device class: 1.

Clearance details

Applicant: Genzyme Corp.
Product code: Code LBS
Device class: Class 1
Regulation: 21 CFR 862.1475
Advisory panel: Clinical Chemistry
Date received: 1997-03-31
Decision date: 1997-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, 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
K132711 — CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT2014-05-08
K120609 — VITROS CHEMISTRY PRODUCTS DHDL SLIDES2012-09-07
K111516 — NMR LIPOPROFILE (R) TEST AND NMR PROFILER2011-09-27

More clearances from Genzyme Corp.

view all

K061508 — OSOM INFLUENZA A&B TEST2006-06-12
K051244 — GENZYME OSOM INFLUENZA A & B TEST2006-02-21
K040241 — N-GENEOUS WIDE RANGE CRP REAGENT AND CALIBRATOR SET2004-06-25
K040868 — SEPRAMESH IP BIORESORBABLE BARRIER - PERMANENT MESH2004-06-04
K033864 — GENZYME OSOM TRICHOMONAS RAPID TEST2004-04-02

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