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 Radioimmunoassay, Digoxin (125-I), Rabbit Antibody, Second Antibody Sep.
510(k) Number K852291
Device Name TIPSEP DIGOXIN RIA
Applicant
Nuclear Diagnostics, Inc.
575 Robbins Dr.
Troy,  MI  48083
Applicant Contact SMART, PH.D
Correspondent
Nuclear Diagnostics, Inc.
575 Robbins Dr.
Troy,  MI  48083
Correspondent Contact SMART, PH.D
Regulation Number862.3320
Classification Product Code
DNL  
Date Received05/29/1985
Decision Date 06/25/1985
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
-
-