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 Antigen, Antiserum, Control, Antithrombin Iii
510(k) Number K780012
Device Name ANTITHROMBIN III RIA
Applicant
Ria Diagnostics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Ria Diagnostics
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number864.7060
Classification Product Code
DDQ  
Date Received01/03/1978
Decision Date 01/20/1978
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-