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 System, Test, Infectious Mononucleosis
510(k) Number K923767
Device Name PULSE IM RED CELL TEST
Applicant
Pulse Scientific, Inc.
5125 Harvester Rd.
Unit 6
Burlington, Ont., Canada,  CA L7L 6A2
Applicant Contact ALLEN CHAN
Correspondent
Pulse Scientific, Inc.
5125 Harvester Rd.
Unit 6
Burlington, Ont., Canada,  CA L7L 6A2
Correspondent Contact ALLEN CHAN
Regulation Number866.5640
Classification Product Code
KTN  
Date Received07/28/1992
Decision Date 10/16/1992
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-