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 Enzyme Immunoassay, Digitoxin
510(k) Number K913240
Device Name DIGITOXIN (FPIA) KIT
Applicant
Tudor Laboratories, Inc.
2170 Lone Star Dr.
Dallas,  TX  75212
Applicant Contact ROBERT M DOWBEN
Correspondent
Tudor Laboratories, Inc.
2170 Lone Star Dr.
Dallas,  TX  75212
Correspondent Contact ROBERT M DOWBEN
Regulation Number862.3300
Classification Product Code
LFM  
Date Received07/22/1991
Decision Date 09/06/1991
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
-
-