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 Blood, Occult, Colorimetric, In Urine
510(k) Number K040703
Device Name URISTIK H SERIES REAGENT STRIPS FOR URINALYSIS
Applicant
Dirui Industrial Co., Ltd.
7560 Lindbergh Dr.
Gaithersburg,  MD  20879
Applicant Contact JOSEPH F LUDFORD
Correspondent
Dirui Industrial Co., Ltd.
7560 Lindbergh Dr.
Gaithersburg,  MD  20879
Correspondent Contact JOSEPH F LUDFORD
Regulation Number864.6550
Classification Product Code
JIO  
Subsequent Product Codes
CDM   CEN   JIL   JIN   JIR  
JJQ   JMA   JMT   JRE   KQO   LJX  
Date Received03/17/2004
Decision Date 08/26/2004
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-