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 probe, nucleic acid amplification, chlamydia
510(k) Number K061413
Device Name APTIMA CT ASSAY ON THE TIGRIS DTS SYSTEM
Applicant
GEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO,  CA  92121 -4362
Applicant Contact BRIAN J SHEA
Correspondent
GEN-PROBE, INC.
10210 GENETIC CENTER DR.
SAN DIEGO,  CA  92121 -4362
Correspondent Contact BRIAN J SHEA
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received05/22/2006
Decision Date 10/13/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Statement Statement
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-