Cleared Traditional

ELVI SGOT & SGPT TRANSAMINASE

K792410 · Volu Sol Medical Industries · Chemistry
Dec 1979
Decision
10d
Days
Class 2
Risk

About This 510(k) Submission

K792410 is an FDA 510(k) clearance for the ELVI SGOT & SGPT TRANSAMINASE, a Hydrazone Colorimetry, Ast/sgot (Class II — Special Controls, product code CIS), submitted by Volu Sol Medical Industries (Mchenry, US). The FDA issued a Cleared decision on December 6, 1979, 10 days after receiving the submission on November 26, 1979. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K792410 FDA.gov
FDA Decision Cleared SESE
Date Received November 26, 1979
Decision Date December 06, 1979
Days to Decision 10 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CIS — Hydrazone Colorimetry, Ast/sgot
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1100