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 Fluorescent Immunoassay Gentamicin
510(k) Number K800032
Device Name FIAX TEST KIT FOR GENTAMICIN QUAN.
Applicant
Intl. Diagnostic Technology
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Intl. Diagnostic Technology
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3450
Classification Product Code
LCQ  
Date Received01/07/1980
Decision Date 01/23/1980
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-