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, Total Triiodothyronine
510(k) Number K926345
Device Name TRIODOTHYRONINE (TC) COATED TUBE RIA
Applicant
Monobind
729 W. 16th St., C-4
Costa Mesa,  CA  92627
Applicant Contact FREDERICK R JEROME
Correspondent
Monobind
729 W. 16th St., C-4
Costa Mesa,  CA  92627
Correspondent Contact FREDERICK R JEROME
Regulation Number862.1710
Classification Product Code
CDP  
Date Received12/17/1992
Decision Date 02/25/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-