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 Back To Search Results
Device Classification Name Dna-Reagents, Neisseria
510(k) Number K043144
Device Name GEN-PROBE APTIMA ASSAY FOR NEISSERIA GONORRHOEAE
Applicant
GEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO,  CA  92121 -4362
Applicant Contact ALAN MADERAZO
Correspondent
GEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO,  CA  92121 -4362
Correspondent Contact ALAN MADERAZO
Regulation Number866.3390
Classification Product Code
LSL  
Date Received11/15/2004
Decision Date 03/14/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-