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 assay, erythropoietin
510(k) Number K936016
Device Name QUANTIKINE IVD ERYTHROPOIETIN ENZYME LINKED IMMUNOSORBENT ASSAY (ELISA)
Applicant
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS,  MN  55413
Applicant Contact JOHN G YAGER
Correspondent
R & D SYSTEMS, INC.
614 MCKINLEY PL., N.E.
MINNEAPOLIS,  MN  55413
Correspondent Contact JOHN G YAGER
Regulation Number864.7250
Classification Product Code
GGT  
Date Received12/16/1993
Decision Date 07/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-