Cleared Traditional

SGOT REAGENT SET

K841065 · Medical Specialties, Inc. · Chemistry
May 1984
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K841065 is an FDA 510(k) clearance for the SGOT REAGENT SET, a Diazo, Ast/sgot (Class II — Special Controls, product code CIQ), submitted by Medical Specialties, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 1, 1984, 50 days after receiving the submission on March 12, 1984. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K841065 FDA.gov
FDA Decision Cleared SESE
Date Received March 12, 1984
Decision Date May 01, 1984
Days to Decision 50 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