Cleared Traditional

K813056 - AUTOMATED URINALYSIS SYSTEM

K813056 is the FDA 510(k) clearance for AUTOMATED URINALYSIS SYSTEM by Kyoto Daiichi Kagaku Co., Ltd.. It is a Class 1 Chemistry device (product code KQO) cleared through the Traditional 510(k) pathway after a 188-day FDA review.

K813056 · Kyoto Daiichi Kagaku Co., Ltd. · Chemistry device
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May 1982
Decision
188d
Days
Class 1
Risk

K813056 is an FDA 510(k) clearance for the AUTOMATED URINALYSIS SYSTEM. Classified as Automated Urinalysis System (product code KQO), Class I - General Controls.

Submitted by Kyoto Daiichi Kagaku Co., Ltd. (Walker, US). The FDA issued a Cleared decision on May 5, 1982 after a review of 188 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2900 - the FDA in vitro diagnostics and chemistry framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Chemistry review framework, consistent with the majority of Class II 510(k) submissions.

View all Kyoto Daiichi Kagaku Co., Ltd. devices

Submission Details

510(k) Number K813056 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 29, 1981
Decision Date May 05, 1982
Days to Decision 188 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d slower than avg
Panel avg: 88d · This submission: 188d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KQO Automated Urinalysis System
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KQO Automated Urinalysis System

All 22
Devices cleared under the same product code (KQO) and FDA review panel - the closest regulatory comparables to K813056.
CLINITEK 200 SEMI-AUTOMATED URINALYSIS
K842237 · Miles Laboratories, Inc. · Aug 1984
CLINITEK 10 SEMI-AUTO URINALYSIS SYS
K842238 · Miles Laboratories, Inc. · Jul 1984
CLINI-TEK SEMI-AUTOMATED URINALYSIS SYST
K821738 · Miles Laboratories, Inc. · Jul 1982
CLINILAB AUTOMATED URINALYSIS SYSTEM
K761306 · Miles Laboratories, Inc. · Mar 1977
INSTRUMENTED SYSTEM FOR URINALYSIS
K760472 · Miles Laboratories, Inc. · Oct 1976