Cleared Traditional

GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET

K855189 · Technostics Intl. · Chemistry
Jan 1986
Decision
19d
Days
Class 2
Risk

About This 510(k) Submission

K855189 is an FDA 510(k) clearance for the GLUTAMIC OXALOACETIC TRANSAMINASE REAGENT SET, a Diazo, Ast/sgot (Class II — Special Controls, product code CIQ), submitted by Technostics Intl. (Washington, US). The FDA issued a Cleared decision on January 14, 1986, 19 days after receiving the submission on December 26, 1985. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K855189 FDA.gov
FDA Decision Cleared SESE
Date Received December 26, 1985
Decision Date January 14, 1986
Days to Decision 19 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