Cleared Traditional

CITREX HOSPITAL SPRAY DISINFECTANT

K982985 · Caltech Industries, Inc. · General Hospital
Nov 1998
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K982985 is an FDA 510(k) clearance for the CITREX HOSPITAL SPRAY DISINFECTANT, a Disinfectant, Medical Devices (Class I — General Controls, product code LRJ), submitted by Caltech Industries, Inc. (Midland, US). The FDA issued a Cleared decision on November 2, 1998, 68 days after receiving the submission on August 26, 1998. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.6890.

Submission Details

510(k) Number K982985 FDA.gov
FDA Decision Cleared SESE
Date Received August 26, 1998
Decision Date November 02, 1998
Days to Decision 68 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement

Device Classification

Product Code LRJ — Disinfectant, Medical Devices
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.6890