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 Culture Media, Non-Selective And Non-Differential
510(k) Number K850658
Device Name CAMPYLOBACTER BLOOD-FREE SELECTIVE AGAR BASE
Applicant
Oxoid U.S.A., Inc.
9017 Red Branch Rd.
Columbia,  MD  21045
Applicant Contact RUTH KEMP
Correspondent
Oxoid U.S.A., Inc.
9017 Red Branch Rd.
Columbia,  MD  21045
Correspondent Contact RUTH KEMP
Regulation Number866.2300
Classification Product Code
JSG  
Date Received02/15/1985
Decision Date 03/20/1985
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
-
-