Cleared Traditional

COULTER TRIGLYCERIDES GPO REAGENT

K897159 · Coulter Electronics, Inc. · Chemistry
Mar 1990
Decision
71d
Days
Class 1
Risk

About This 510(k) Submission

K897159 is an FDA 510(k) clearance for the COULTER TRIGLYCERIDES GPO REAGENT, a Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides (Class I — General Controls, product code CDT), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on March 9, 1990, 71 days after receiving the submission on December 28, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1705.

Submission Details

510(k) Number K897159 FDA.gov
FDA Decision Cleared SESE
Date Received December 28, 1989
Decision Date March 09, 1990
Days to Decision 71 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CDT — Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1705

Similar Devices — CDT Lipase Hydrolysis/glycerol Kinase Enzyme, Triglycerides

All 150
Triglycerides
K150819 · Randox Laboratories Limited · Aug 2015
ADVIA CHEMISTRY TRIGLYCERIDES_2 (TRIG_2) REAGENT
K133067 · Siemens Healthcare Diagnostics, Inc. · Nov 2013
VITROS CHEMISTRY PRODUCTS TRIG SLIDES
K130332 · Ortho-Clinical Diagnostics, Inc. · May 2013
VANTERA CLINICAL ANALYZER
K113830 · Liposcience · Aug 2012
ELITECH CLINICAL SYSTEMS TRIGLYCERIDES SL, ELITECH CLINICAL SYSTEMS CHOLESTEROL SL
K102993 · Seppim S.A.S. · May 2011
OLYMPUS TRIGLYCERIDE TEST SYSTEM
K063804 · Olympus America, Inc. · Mar 2007