• 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 Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name separator, automated, blood cell, diagnostic
510(k) Number DK760856
Tradename IBM 2991 Blood Cell Processor, Model 2
Device Name Automated Blood Cell Separator -Filtration
Original Applicant
International Business Machines
princeton,  NJ  08540
Regulation Number864.9245
Classification Product Code
Date Received10/15/1976
Decision Date 01/10/1977
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Traditional
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No