Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Method, Enzymatic, Glucose (Urinary, Non-Quantitative)
510(k) Number K932369
FOIA Releasable 510(k) K932369
Device Name UROPAPER EIKEN 7
Applicant
Tanabe U.S.A., Inc.
P.O. Box 85132
San Diego,  CA  92186
Applicant Contact HIROSHI SUGANO
Correspondent
Tanabe U.S.A., Inc.
P.O. Box 85132
San Diego,  CA  92186
Correspondent Contact HIROSHI SUGANO
Regulation Number862.1340
Classification Product Code
JIL  
Date Received04/19/1993
Decision Date 11/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-