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 K883486
Device Name GONOSTAT
Applicant
Technology Management & Marketing, Inc.
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Applicant Contact JOSEPH R RADZIUS
Correspondent
Technology Management & Marketing, Inc.
333 W. Wacker Dr.
Suite 1900
Chicago,  IL  60606
Correspondent Contact JOSEPH R RADZIUS
Regulation Number866.3390
Classification Product Code
LSL  
Date Received08/16/1988
Decision Date 08/15/1989
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
-
-