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 Alkaline Picrate, Colorimetry, Creatinine
510(k) Number K943924
Device Name CREATININE-PO REAGENT KIT
Applicant
Synermed, Inc.
1688 50th Ave.,
Montreal (Lachine),
Quebec, Canada,  CA H8T 2V5
Applicant Contact MARCIA J ARTENZ
Correspondent
Synermed, Inc.
1688 50th Ave.,
Montreal (Lachine),
Quebec, Canada,  CA H8T 2V5
Correspondent Contact MARCIA J ARTENZ
Regulation Number862.1225
Classification Product Code
CGX  
Date Received08/12/1994
Decision Date 09/20/1994
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
-
-