Cleared Traditional

COBAS READY AST REAGENT

K896238 · Roche Diagnostic Systems, Inc. · Chemistry
Feb 1990
Decision
109d
Days
Class 2
Risk

About This 510(k) Submission

K896238 is an FDA 510(k) clearance for the COBAS READY AST REAGENT, a Hydrazone Colorimetry, Ast/sgot (Class II — Special Controls, product code CIS), submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on February 16, 1990, 109 days after receiving the submission on October 30, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1100.

Submission Details

510(k) Number K896238 FDA.gov
FDA Decision Cleared SESE
Date Received October 30, 1989
Decision Date February 16, 1990
Days to Decision 109 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