Cleared Traditional

AMMONIA TEST

K813366 · Wako Pure Chemical Industries, Ltd. · Chemistry
Dec 1981
Decision
22d
Days
Class 1
Risk

About This 510(k) Submission

K813366 is an FDA 510(k) clearance for the AMMONIA TEST, a Photometric Method, Ammonia (Class I — General Controls, product code JID), submitted by Wako Pure Chemical Industries, Ltd. (Mchenry, US). The FDA issued a Cleared decision on December 22, 1981, 22 days after receiving the submission on November 30, 1981. This device falls under the Chemistry review panel. Regulated under 21 CFR 862.1065.

Submission Details

510(k) Number K813366 FDA.gov
FDA Decision Cleared SESE
Date Received November 30, 1981
Decision Date December 22, 1981
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary —

Device Classification

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