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 System, Fibrinogen Determination
510(k) Number K934326
Device Name MULTIFIBREN U
Applicant
BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Applicant Contact LORI BARANAUSKAS
Correspondent
BEHRING DIAGNOSTICS, INC.
151 UNIVERSITY AVE.
WESTWOOD,  MA  02090
Correspondent Contact LORI BARANAUSKAS
Regulation Number864.7340
Classification Product Code
KQJ  
Date Received09/03/1993
Decision Date 04/19/1994
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
-
-