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 Biologics Clearance Letters and 510(k) Summaries Back To Search Results
Device Classification Name blood establishment computer software and accessories
510(k) Number BK040087
Tradename BBCS Lab Interface Application (BBCS Lab)
Device Name Blood Establishment Computer Software and Accessories
Original Applicant
Blood Bank Computer Systems, Inc.
1002 15th st. sw, suite 120
auburn,  WA  98001 6502
Regulation Number864.9165
Classification Product Code
MMH  
Date Received12/17/2004
Decision Date 02/15/2005
Decision substantially equivalent (SE)
Classification Advisory Committee Hematology
Review Advisory Committee Hematology
Type 510(k) Abbreviated
Total Product Life Cycle (TPLC) TPLC Device Report
Reviewed by Third Party No
Expedited Review No
Combination Product No
In Vitro Product No
-
-