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 K901243
Device Name CHLAMYDIA-CEL IMMUNOFLUORENSCENCE (IF) TEST
Applicant
Cel Labs Pty, Ltd.
1120 Vermont Ave., NW
Suite 600
Washington,  DC  20005
Applicant Contact MACKLER, PHD
Correspondent
Cel Labs Pty, Ltd.
1120 Vermont Ave., NW
Suite 600
Washington,  DC  20005
Correspondent Contact MACKLER, PHD
Regulation Number866.3120
Classification Product Code
LJP  
Date Received03/15/1990
Decision Date 05/21/1990
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
-
-