Cleared Traditional

K911838 - ROCHE REAGENT FOR C02
(FDA 510(k) Clearance)

K911838 · Roche Diagnostic Systems, Inc. · Chemistry device

Jul 1991

Decision

85d

Days

Class 2

Risk

K911838 is an FDA 510(k) clearance for the ROCHE REAGENT FOR C02. This device is classified as a Coulometric Method, Carbon-dioxide (Class II - Special Controls, product code CHS).

Submitted by Roche Diagnostic Systems, Inc. (Montclair, US). The FDA issued a Cleared decision on July 19, 1991, 85 days after receiving the submission on April 25, 1991.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1160.

Submission Details

510(k) Number	K911838 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	April 25, 1991
Decision Date	July 19, 1991
Days to Decision	85 days
Submission Type	Traditional
Review Panel	Chemistry (CH)
Summary	Statement