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 Prealbumin, Antigen, Antiserum, Control
510(k) Number K850686
Device Name ANTISERUM TO HUMAN PREALBUMIN
Applicant
Kent Laboratories, Inc.
23404 NE 8th St.
Redmond,  WA  98053
Applicant Contact ALLAN H JORGENSEN
Correspondent
Kent Laboratories, Inc.
23404 NE 8th St.
Redmond,  WA  98053
Correspondent Contact ALLAN H JORGENSEN
Regulation Number866.5060
Classification Product Code
JZJ  
Date Received02/21/1985
Decision Date 11/01/1985
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
-
-