• 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 dna-reagents, neisseria
510(k) Number K984631
Device Name BDPROBETEC ET CHLAMYDIA TRACHOMATIS AND NEISSERIA GONORRHOEAE AMPLIFIED DNA ASSAY
Original Applicant
BECTON DICKINSON MICROBIOLOGY SYSTEMS
7 loveton cir.
sparks,  MD  21152 0999
Original Contact colleen rohrbeck
Regulation Number866.3390
Classification Product Code
LSL  
Subsequent Product Code
MKZ  
Date Received12/30/1998
Decision Date 11/04/1999
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
Recalls CDRH Recalls
-
-