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 Plasma, Coagulation Factor Deficient
510(k) Number K031829
Device Name HEMOSIL FACTOR IX DEFICIENT PLASMA
Applicant
Instrumentation Laboratory CO
526 Rt. 303
Orangeburg,  NY  10962
Applicant Contact CAROL MARBLE
Correspondent
Instrumentation Laboratory CO
526 Rt. 303
Orangeburg,  NY  10962
Correspondent Contact CAROL MARBLE
Regulation Number864.7290
Classification Product Code
GJT  
Subsequent Product Code
GGP  
Date Received06/13/2003
Decision Date 07/31/2003
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-