Cleared Traditional

SPIFE CHOLESTEROL PROFILE KIT

K000603 · Helena Laboratories · Chemistry
Apr 2000
Decision
54d
Days
Class 1
Risk

About This 510(k) Submission

K000603 is an FDA 510(k) clearance for the SPIFE CHOLESTEROL PROFILE KIT, a Electrophoretic Separation, Lipoproteins (Class I — General Controls, product code JHO), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on April 17, 2000, 54 days after receiving the submission on February 23, 2000. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number K000603 FDA.gov
FDA Decision Cleared SESE
Date Received February 23, 2000
Decision Date April 17, 2000
Days to Decision 54 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code JHO — Electrophoretic Separation, Lipoproteins
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1475

Similar Devices — JHO Electrophoretic Separation, Lipoproteins

All 25
SPIFE LIPPOROTEIN-12, MODEL 3344
K022333 · Helena Laboratories · Aug 2002
HYDRAGEL 7 LIPOPROTEIN(E), PN 4114 & HYDRAGEL LIPOPROTEIN(E) 15/30 PN 4134
K022053 · Sebia · Jul 2002
MODIFICATION TO LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K013662 · Quantimetrix Corp. · Mar 2002
MODIFIED TO LDL/HDL CHOL DIRECT KIT-P.N. 4005, 4103,4123
K012789 · Morax · Jan 2002
SPIFE 2000/3000 LIPOPROTEIN; MODEL# 3340, 3341, 3342, 3343
K013466 · Helena Laboratories · Dec 2001
LIPOPRINT SYSTEM, LDL SUBFRACTIONS
K010337 · Quantimetrix Corp. · Jul 2001