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 Ige, Antigen, Antiserum, Control
510(k) Number K810507
Device Name PHADEZYM IGE PRIST TEST
Applicant
Pharmacia, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Pharmacia, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number866.5510
Classification Product Code
DGC  
Date Received02/24/1981
Decision Date 03/20/1981
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
-
-