Cleared Traditional

MAGNESIUM (SUBSTRATE, ENZYME, REAGENT)

K860367 · Alpkem Corp. · Chemistry

Apr 1986

Decision

67d

Days

Class 2

Risk

About This 510(k) Submission

K860367 is an FDA 510(k) clearance for the MAGNESIUM (SUBSTRATE, ENZYME, REAGENT), a Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes (Class II — Special Controls, product code JGF), submitted by Alpkem Corp. (Clackamas, US). The FDA issued a Cleared decision on April 11, 1986, 67 days after receiving the submission on February 3, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1445.

Submission Details

510(k) Number	K860367 FDA.gov
FDA Decision	Cleared SESE
Date Received	February 03, 1986
Decision Date	April 11, 1986
Days to Decision	67 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	—

Device Classification

Product Code	JGF — Differential Rate Kinetic Method, Lactate Dehydrogenase Isoenzymes
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 862.1445