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

FDA 510(k) K932368, UROPAPER EIKEN 6B, by Tanabe U.S.A., Inc.

FDA 510(k) K932368, UROPAPER EIKEN 6B, by Tanabe U.S.A., Inc.

$89.00 USD
$89.00 USD
Sale Sold out
510(K) Number: K932368
Device Name: UROPAPER EIKEN 6B
Manufacturer: Tanabe U.S.A., Inc.
Device Classification Name: method, enzymatic, glucose (urinary, non-quantitative)
Regulation Number: 862.1340
Classification Product Code: JIL
Date Received: 04/19/1993
Decision Date: 01/13/1994
Regulation Medical Specialty: Clinical Chemistry
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