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 Antiserum, Fluorescent, Chlamydia Trachomatis
510(k) Number K862354
Device Name MONOFLUOR CHLAMYDIA TRACHOMATIS DIR SPEC TEST KIT
Applicant
Synbiotics Corp.
11011 Via Frontera
San Diego,  CA  92127
Applicant Contact MORTON A VODIAN
Correspondent
Synbiotics Corp.
11011 Via Frontera
San Diego,  CA  92127
Correspondent Contact MORTON A VODIAN
Regulation Number866.3120
Classification Product Code
LJP  
Date Received06/20/1986
Decision Date 09/29/1986
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-