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 biuret (colorimetric), total protein
510(k) Number K903511
Device Name SYNERMED TOTAL PROTEIN REAGENT KIT
Applicant
SYNERMED, INC.
445 BOUL. INDUSTRIEL
ST-EUSTANCHE
QUEBEC,  CA J745R3
Applicant Contact MARCIA J ARENTZ
Correspondent
SYNERMED, INC.
445 BOUL. INDUSTRIEL
ST-EUSTANCHE
QUEBEC,  CA J745R3
Correspondent Contact MARCIA J ARENTZ
Regulation Number862.1635
Classification Product Code
CEK  
Date Received08/03/1990
Decision Date 09/07/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-