Cleared Traditional

ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH

K905861 · E.I. Dupont DE Nemours & Co., Inc. · Chemistry
Feb 1991
Decision
37d
Days
Class 2
Risk

About This 510(k) Submission

K905861 is an FDA 510(k) clearance for the ACA(R) LACTIC DEHYDROGENASE ISOENZYME 1 (LD1) METH, a Electrophoretic, Lactate Dehydrogenase Isoenzymes (Class II — Special Controls, product code CFE), submitted by E.I. Dupont DE Nemours & Co., Inc. (Wilmington, US). The FDA issued a Cleared decision on February 6, 1991, 37 days after receiving the submission on December 31, 1990. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1445.

Submission Details

510(k) Number K905861 FDA.gov
FDA Decision Cleared SESE
Date Received December 31, 1990
Decision Date February 06, 1991
Days to Decision 37 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

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
SPIFE LD VIS ISOENZYME KIT, MODELS 3450, 3451, AND 3452
K020467 · Helena Laboratories · Mar 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