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 Test, Fibrinogen
510(k) Number K913061
Device Name FIBRINOGEN DETERMINATION KIT
Applicant
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Applicant Contact DANIEL E LAWSON
Correspondent
Sigma Diagnostics, Inc.
545 S. Ewing Ave.
St. Louis,  MO  63103
Correspondent Contact DANIEL E LAWSON
Regulation Number864.7340
Classification Product Code
GIS  
Date Received07/10/1991
Decision Date 10/09/1991
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
-
-