• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name assay, nucleic acid amplification, growth identification, mycobacterium tuberculosis
510(k) Number K000884
Device Name BD PROBETEC ET MYCOBACTERIUM TUBERCULOSIS COMPLEX (CTB) CULTURE IDENTIFICATION ASSAY
Original Applicant
BECTON DICKINSON BIOSCIENCES
7 loveton circle
sparks,  MD  21152
Original Contact colleen rohrbeck
Regulation Number866.3370
Classification Product Code
NDZ  
Date Received03/20/2000
Decision Date 01/19/2001
Decision substantially equivalent (SE)
Classification Advisory Committee Microbiology
Review Advisory Committee Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-