Cleared Traditional

K821209 - SGOT REAGENT SET
(FDA 510(k) Clearance)

K821209 · Omega Medical Electronics · Chemistry
Jul 1982
Decision
78d
Days
Class 2
Risk

K821209 is an FDA 510(k) clearance for the SGOT REAGENT SET. This device is classified as a Diazo, Ast/sgot (Class II — Special Controls, product code CIQ).

Submitted by Omega Medical Electronics (Mchenry, US). The FDA issued a Cleared decision on July 14, 1982, 78 days after receiving the submission on April 27, 1982.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K821209 FDA.gov
FDA Decision Cleared SESE
Date Received April 27, 1982
Decision Date July 14, 1982
Days to Decision 78 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIQ — Diazo, Ast/sgot
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1100