• 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 K973707
Device Name ROCHE AMPLICOR CT/NG TEST FOR CHLAMYDIA TRACHOMATIS
Applicant
ROCHE MOLECULAR SYSTEMS, INC.
1080 U.S. HIGHWAY 202
somerville,  NJ  08876 -3711
Applicant Contact alex wesolowski
Correspondent
ROCHE MOLECULAR SYSTEMS, INC.
1080 U.S. HIGHWAY 202
somerville,  NJ  08876 -3711
Correspondent Contact alex wesolowski
Regulation Number866.3120
Classification Product Code
MKZ  
Date Received09/29/1997
Decision Date 08/04/1999
Decision substantially equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-