• 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 Culture Media, Anaerobic Transport
510(k) Number K925450
Device Name BIONOR TRANSPORTMEDIUM
Applicant
Skoug Research Corp.
P.O. Box 405
Cambridge,  MA  02141
Applicant Contact ERIK SKOUG
Correspondent
Skoug Research Corp.
P.O. Box 405
Cambridge,  MA  02141
Correspondent Contact ERIK SKOUG
Regulation Number866.2390
Classification Product Code
JSL  
Date Received10/28/1992
Decision Date 06/25/1993
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
-
-