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 K070172
Device Name AMPLICOR CT/NG TEST FOR NEISSERIA GONORRHOEAE
Applicant
ROCHE DIAGNOSTICS CORPORATION
9115 hague road
indianapolis,  IN  46256
Applicant Contact theresa ambrose bush
Correspondent
ROCHE DIAGNOSTICS CORPORATION
9115 hague road
indianapolis,  IN  46256
Correspondent Contact theresa ambrose bush
Regulation Number866.3390
Classification Product Code
LSL  
Date Received01/18/2007
Decision Date 04/17/2007
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-