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, Primary
510(k) Number K940008
Device Name GLYCATED PROTEIN CALIBRATORS
Applicant
Primus Corp.
P.O. Box 22599
Kansas City,  MO  64113
Applicant Contact RICK HARRISON
Correspondent
Primus Corp.
P.O. Box 22599
Kansas City,  MO  64113
Correspondent Contact RICK HARRISON
Regulation Number862.1150
Classification Product Code
JIS  
Date Received01/04/1994
Decision Date 05/09/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-