Cleared Traditional

ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD)

K881173 · Tech-Co, Inc. · Chemistry
Jun 1988
Decision
81d
Days
Class 2
Risk

About This 510(k) Submission

K881173 is an FDA 510(k) clearance for the ASPARTATE AMINOTRANSFERASE (COLORIMETRIC METHOD), a Diazo, Ast/sgot (Class II — Special Controls, product code CIQ), submitted by Tech-Co, Inc. (Oak Park, US). The FDA issued a Cleared decision on June 7, 1988, 81 days after receiving the submission on March 18, 1988. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K881173 FDA.gov
FDA Decision Cleared SESE
Date Received March 18, 1988
Decision Date June 07, 1988
Days to Decision 81 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