Cleared Traditional

K823364 - COUNT-10 SYSTEM FOR STAND. URINALYSIS

K823364 is the FDA 510(k) clearance for COUNT-10 SYSTEM FOR STAND. URINALYSIS by V-Tech, Inc.. It is a Class 1 Chemistry device (product code JQW) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K823364 · V-Tech, Inc. · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1982
Decision
36d
Days
Class 1
Risk

K823364 is an FDA 510(k) clearance for the COUNT-10 SYSTEM FOR STAND. URINALYSIS. Classified as Station, Pipetting And Diluting, For Clinical Use (product code JQW), Class I - General Controls.

Submitted by V-Tech, Inc. (Walker, US). The FDA issued a Cleared decision on December 15, 1982 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 862.2750 - 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all V-Tech, Inc. devices

Submission Details

510(k) Number K823364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1982
Decision Date December 15, 1982
Days to Decision 36 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
52d faster than avg
Panel avg: 88d · This submission: 36d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code JQW Station, Pipetting And Diluting, For Clinical Use
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 862.2750
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 - JQW Station, Pipetting And Diluting, For Clinical Use

All 64
Devices cleared under the same product code (JQW) and FDA review panel - the closest regulatory comparables to K823364.
PRO QUANTUM
K831249 · Abbott Laboratories · Jul 1983
QST TM SAMPLE PROCESSOR
K831273 · Syva Co. · Jun 1983
DIGIFLEX AUTOMATIC PIPETTE
K830157 · Micromedic Systems · Mar 1983
MULTIWASH
K813426 · Flow Laboratories, Inc. · Dec 1981
DISPENSER ASPIRATOR DA 300
K812782 · Pharmacia, Inc. · Oct 1981
EMIT AUTO CAROUSEL
K812647 · Syva Co. · Oct 1981