Cleared Traditional

COBAS READY ALT REAGENT

K896237 · Roche Diagnostic Systems, Inc. · Chemistry
Feb 1990
Decision
108d
Days
Class 1
Risk

About This 510(k) Submission

K896237 is an FDA 510(k) clearance for the COBAS READY ALT REAGENT, a Hydrazone Colorimetry, Alt/sgpt (Class I — General Controls, product code CKD), submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on February 16, 1990, 108 days after receiving the submission on October 31, 1989. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1030.

Submission Details

510(k) Number K896237 FDA.gov
FDA Decision Cleared SESE
Date Received October 31, 1989
Decision Date February 16, 1990
Days to Decision 108 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

Product Code CKD — Hydrazone Colorimetry, Alt/sgpt
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1030

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