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 test, residual, wbc in leukoreduced blood
510(k) Number BK210621
Tradename r-Control RBC and PLT
Device Name Test, Residual, WBC in Leukoreduced Blood
Original Applicant
Nanoentek, Inc.
nanoentek, inc.
851-14 seohae-ro, paltan-myeon
09  Hwaseong-si,  18531, 
Regulation Number864.8625
Classification Product Code
MZG  
Date Received08/04/2021
Decision Date 10/28/2021
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 Yes
-
-