Cleared Traditional

SGOT (AST) REAGENT SET

K860216 · Sterling Diagnostics, Inc. · Chemistry
Apr 1986
Decision
71d
Days
Class 2
Risk

About This 510(k) Submission

K860216 is an FDA 510(k) clearance for the SGOT (AST) REAGENT SET, a Diazo, Ast/sgot (Class II — Special Controls, product code CIQ), submitted by Sterling Diagnostics, Inc. (Sterling Heights, US). The FDA issued a Cleared decision on April 3, 1986, 71 days after receiving the submission on January 22, 1986. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K860216 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 1986
Decision Date April 03, 1986
Days to Decision 71 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