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 Ferritin, Antigen, Antiserum, Control
510(k) Number K911175
Device Name SRI FERRITIN IMMOENZYMETRIC ASSAY(MAG SOLID-PHASE)
Applicant
Serono-Baker Diagnostics, Inc.
100 Cascade Dr.
Allentown,  PA  18103
Applicant Contact DAVID B THOMAS
Correspondent
Serono-Baker Diagnostics, Inc.
100 Cascade Dr.
Allentown,  PA  18103
Correspondent Contact DAVID B THOMAS
Regulation Number866.5340
Classification Product Code
DBF  
Date Received03/18/1991
Decision Date 04/05/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-