Cleared Traditional

SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452

K020467 · Helena Laboratories · Chemistry
Mar 2002
Decision
45d
Days
Class 2
Risk

About This 510(k) Submission

K020467 is an FDA 510(k) clearance for the SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452, a Electrophoretic, Lactate Dehydrogenase Isoenzymes (Class II — Special Controls, product code CFE), submitted by Helena Laboratories (Beaumont, US). The FDA issued a Cleared decision on March 29, 2002, 45 days after receiving the submission on February 12, 2002. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1445.

Submission Details

510(k) Number K020467 FDA.gov
FDA Decision Cleared SESE
Date Received February 12, 2002
Decision Date March 29, 2002
Days to Decision 45 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Statement

Device Classification

Product Code CFE — Electrophoretic, Lactate Dehydrogenase Isoenzymes
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1445

Similar Devices — CFE Electrophoretic, Lactate Dehydrogenase Isoenzymes

All 27
GELSCAN, MODEL 1206
K100307 · Sebia · Aug 2010
SPIFE LD-12 KIT, MODEL 3338
K022455 · Helena Laboratories · Oct 2002
HYRAGEL ISO-LDH KIT/HYDRAGEL 15 ISO-LDH KIT
K970477 · Sebia · Mar 1997
CARDIO REP LD
K940224 · Helena Laboratories · Aug 1994
ACA LACTATE DEHYDROGENASE ISOENZYME 1 (LD1) METHOD
K921455 · E.I. Dupont DE Nemours & Co., Inc. · Apr 1992
ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH
K905861 · E.I. Dupont DE Nemours & Co., Inc. · Feb 1991