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 Enzyme Linked Immunoabsorbent Assay, Rubella
510(k) Number K950227
Device Name RUBELISA (RUBESTAT)
Applicant
Bio-Whittaker, Inc., A Cambrex Co.
8830 Biggs Ford Rd.
Walkersville,  MD  21793
Applicant Contact LEIF E OLSEN
Correspondent
Bio-Whittaker, Inc., A Cambrex Co.
8830 Biggs Ford Rd.
Walkersville,  MD  21793
Correspondent Contact LEIF E OLSEN
Regulation Number866.3510
Classification Product Code
LFX  
Date Received01/10/1995
Decision Date 08/15/1995
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Microbiology
510k Review Panel Microbiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-