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 system, detection, bacterial, for platelet transfusion products
510(k) Number BK130017
Tradenames BacTx Reader, BacTx Software, BacTx® Bacterial Detection Kit for Detection of Bacteria in Platelets
Device Name System, Detection, Bacterial, Detection Systems for Platelet Transfusion Products
Original Applicant
Immunetics, Inc.
27 drydock avenue
boston,  MA  02210 2377
Regulation Number866.2560
Classification Product Code
MZC  
Date Received03/25/2013
Decision Date 08/12/2013
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Immunology
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 Yes
-
-