• FDA DYMISTA NDA 202236 approval records — 22 FDA documents, 848 pages
1 1

FDA 510(k) K160062, AUTION ELEVEN Semi-Automated Urinalysis System, by Arkray, Inc.

FDA 510(k) K160062, AUTION ELEVEN Semi-Automated Urinalysis System, by Arkray, Inc.

$3,035.09 USD
$3,035.09 USD
Sale Sold out

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)
View full details
FOIA Pro

This drug has a lot more FDA history than one product page can show

FOIA Pro gives you full-text search across 70,000+ FDA FOIA records, from 2020 through today, plus a monthly monitor tracking new requests as they close.
  • Full-text search across every FDA FOIA log since 2020
  • Warning letters, approval records, and correspondence in one place
  • Monthly FDA FOIA Monitor newsletter, included
  • Cancel anytime, monthly or annual billing
Get FOIA Pro
Live search · FOIA database
Searching related FDA records…
ClosedTypeSubjectOutcome