• 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 counter, differential cell
510(k) Number K060375
Device Name BD MULTITEST 6-COLOR TBNK REAGENT WITH BD TRUCOUNT TUBES WITH MODELS 337 AND 166
Applicant
BD Biosciences
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Applicant Contact CARTER NAVARRO
Correspondent
BD Biosciences
2350 QUME DR.
SAN JOSE,  CA  95131 -1807
Correspondent Contact CARTER NAVARRO
Regulation Number864.5220
Classification Product Code
GKZ  
Date Received02/13/2006
Decision Date 06/06/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-