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 Immunoassay, Insulin-Like Growth Factor Binding Protein-1
510(k) Number K061886
Device Name ACTIM PROM AND CONTROLS
Applicant
Medix Biochemica
49 Plain St.
North Attleboro,  MA  02760
Applicant Contact CYNTHIA SINCLAIR
Correspondent
Medix Biochemica
49 Plain St.
North Attleboro,  MA  02760
Correspondent Contact CYNTHIA SINCLAIR
Regulation Number862.1550
Classification Product Code
OAM  
Subsequent Product Code
JJX  
Date Received07/03/2006
Decision Date 01/25/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-