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 Complement C3, Antigen, Antiserum, Control
510(k) Number K964842
Device Name IMMAGE IMMUNOCHEMISTRY SYSTEM COMPLEMENTC3 (C3) AND COMPLEMENTC4 (C4) REAGENT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-343
Brea,  CA  92822
Applicant Contact MARGIE GEORGE
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
W-343
Brea,  CA  92822
Correspondent Contact MARGIE GEORGE
Regulation Number866.5240
Classification Product Code
CZW  
Subsequent Product Codes
DBI   JIX  
Date Received12/03/1996
Decision Date 06/11/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Immunology
510k Review Panel Immunology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-