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 Differential Rate Kinetic Method, Cpk Or Isoenzymes
510(k) Number K943024
Device Name KINASE ISOENZYME
Applicant
Dupont Medical Products
P.O. Box 80022
Bmp 22/1158
Wilmington,  DE  19880
Applicant Contact CATHY P CRAFT
Correspondent
Dupont Medical Products
P.O. Box 80022
Bmp 22/1158
Wilmington,  DE  19880
Correspondent Contact CATHY P CRAFT
Regulation Number862.1215
Classification Product Code
JHS  
Subsequent Product Code
JHT  
Date Received05/26/1994
Decision Date 08/02/1994
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
-
-