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 Anti-Sm Antibody, Antigen And Control
510(k) Number K000312
Device Name VARELISA SM ANTIBODIES
Applicant
Pharmacia & Upjohn Co.
5094 St. Andrews Dr.
Westervillle,  OH  43082
Applicant Contact KAREN MATIS
Correspondent
Pharmacia & Upjohn Co.
5094 St. Andrews Dr.
Westervillle,  OH  43082
Correspondent Contact KAREN MATIS
Regulation Number866.5100
Classification Product Code
LKP  
Date Received02/01/2000
Decision Date 03/17/2000
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
-
-