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 Calibrator, Secondary
510(k) Number K934843
Device Name URINARY/CEBROSPINAL FLUID PROTEIN CALIBRATOR
Applicant
E.I. Dupont DE Nemours & Co., Inc.
Bmp22/1170
Wilmington,  DE  19880
Applicant Contact CAROLYN K GEORGE
Correspondent
E.I. Dupont DE Nemours & Co., Inc.
Bmp22/1170
Wilmington,  DE  19880
Correspondent Contact CAROLYN K GEORGE
Regulation Number862.1150
Classification Product Code
JIT  
Date Received10/08/1993
Decision Date 03/11/1994
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
-
-