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 Diazo Colorimetry, Bilirubin
510(k) Number K862359
Device Name METH./CALI./INTRU. CHECK FOR THE DIMENSION SYSTEM
Applicant
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON,  DE  19898
Applicant Contact GRACE H SINGLES
Correspondent
E.I. DUPONT DE NEMOURS & CO., INC.
MEDICAL PRODUCTS DEPARTMENT
BARLEY MILL PLAZA, P22-1170
WILMINGTON,  DE  19898
Correspondent Contact GRACE H SINGLES
Regulation Number862.1110
Classification Product Code
CIG  
Date Received06/23/1986
Decision Date 08/19/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-