• 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, free thyroxine
510(k) Number K934012
Device Name FT4 RADIOIMMUNOASSAY
Applicant
IMMUNOTECH S.A.
13276 MARSILLE CEDEX 9
FRANCE,  FR
Applicant Contact P. PRINCE
Correspondent
IMMUNOTECH S.A.
13276 MARSILLE CEDEX 9
FRANCE,  FR
Correspondent Contact P. PRINCE
Regulation Number862.1695
Classification Product Code
CEC  
Date Received08/18/1993
Decision Date 11/16/1993
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-