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 Automated Urinalysis System
510(k) Number K870526
Device Name SUPER URINE ANALYZER SYSTEM
Applicant
Kyoto Daiichi Kagaku Co., Ltd.
57 Nishi Aketa Cho
Higashi Kujo Minami Ku
Kyoto, 601,  JP
Applicant Contact SHIGEKI YAMADA
Correspondent
Kyoto Daiichi Kagaku Co., Ltd.
57 Nishi Aketa Cho
Higashi Kujo Minami Ku
Kyoto, 601,  JP
Correspondent Contact SHIGEKI YAMADA
Regulation Number862.2900
Classification Product Code
KQO  
Date Received02/06/1987
Decision Date 03/06/1987
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
-
-