Cleared Traditional

APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201

K080125 · Wako Chemicals USA, Inc. · Chemistry
Jul 2008
Decision
183d
Days
Class 1
Risk

About This 510(k) Submission

K080125 is an FDA 510(k) clearance for the APOLOWAKO T-CHO, HDL-C, TG AND ANALYZER, MODELS 993-23501, 999-23601, 995-23701 AND 993-25201, a Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl (Class I — General Controls, product code LBS), submitted by Wako Chemicals USA, Inc. (Richmond, US). The FDA issued a Cleared decision on July 18, 2008, 183 days after receiving the submission on January 17, 2008. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K080125 FDA.gov
FDA Decision Cleared SESE
Date Received January 17, 2008
Decision Date July 18, 2008
Days to Decision 183 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code LBS — Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

Similar Devices — LBS Ldl & Vldl Precipitation, Cholesterol Via Esterase-oxidase, Hdl

All 79
HDL-Cholesterol Gen.4
K162593 · Roche Diagnostics Operations (Rdo) · Oct 2016
Direct HDL Cholesterol (HDL)
K153435 · Randox Laboratories, Ltd. · Jan 2016
CAROLINA LIQUID CHEMISTRIES HDL CHOLESTEROL REAGENT
K132711 · Carolina Liquid Chemistries Corp. · May 2014
VITROS CHEMISTRY PRODUCTS DHDL SLIDES
K120609 · Ortho-Clinical Diagnostics, Inc. · Sep 2012
NMR LIPOPROFILE (R) TEST AND NMR PROFILER
K111516 · Liposcience, Inc. · Sep 2011
ELITECH CLINCAL SYSTEMS CHOLESTEROL HDL SL 2G, HDL 2G CALIBRATOR, LDL SL 2G, LDL 2G CALIBRATOR, ELITROL II & ELITECH SYS
K103747 · Elitechgroup Seppim S.A.S. · Aug 2011

More from Wako Chemicals USA, Inc.

View all
UTASWAKO I30 (INCLUDES ACCESSORIES), UTASWAKO AFP-L3, CALIBRATOR SET, CONTROL L, CONTROL H, SAMPLE DILUTION
K100464 · NSF · Feb 2011
APOLOWAKO HBA1C, GLUCOSE AND ANALYZER, MODELS 993-24601, 991-24401 AND 993-25201
K080123 · CFR · Jul 2008
WAKO L-TYPE CREATININE-M TEST, AND WAKO CREATININE CALIBRATOR
K061775 · JFY · Feb 2007
WAKO LBA DCP TEST SYSTEM, MODEL 993-05301; DCP CONTROL SET, MODEL 995-0551; DCP CALIBRATOR SET, LIBASYS, MODEL 999-05401
K062368 · OAU · Jan 2007
WAKO TOTAL BILIRUBIN V, MODELS 410-22701, 998-23291, 416-22801, 990-23191
K053131 · JFM · Dec 2005