Cleared Traditional

CARESIDE AMMONIA

K991371 · Careside, Inc. · Chemistry
Aug 1999
Decision
105d
Days
Class 1
Risk

About This 510(k) Submission

K991371 is an FDA 510(k) clearance for the CARESIDE AMMONIA, a Photometric Method, Ammonia (Class I — General Controls, product code JID), submitted by Careside, Inc. (Culver City, US). The FDA issued a Cleared decision on August 3, 1999, 105 days after receiving the submission on April 20, 1999. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K991371 FDA.gov
FDA Decision Cleared SESE
Date Received April 20, 1999
Decision Date August 03, 1999
Days to Decision 105 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary Summary PDF

Device Classification

Product Code JID — Photometric Method, Ammonia
Device Class Class I — General Controls
CFR Regulation 21 CFR 862.1065