FDA 510(k), K160062, AUTION ELEVEN Semi-Automated Urinalysis System

510(K) Number: K160062
Device Name: AUTION ELEVEN Semi-Automated Urinalysis System
Manufacturer: ARKRAY, Inc.
Device Classification Name: method, enzymatic, glucose (urinary, non-quantitative)
Regulation Number: 862.1340
Classification Product Code: JIL
Date Received: 01/12/2016
Decision Date: 10/07/2016
Regulation Medical Specialty: Clinical Chemistry

1,810 pages (2,291 of 4,101 original pages are fully redacted)