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 Kit, Identification, Enterobacteriaceae
510(k) Number K926017
Device Name CRYSTAL RAPID STOOL/ENTERIC ID SYSTEM
Applicant
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville,  MD  21030 -0243
Applicant Contact ROBERT E JAMES
Correspondent
Becton Dickinson Microbiology Systems
P.O. Box 243
Cockeysville,  MD  21030 -0243
Correspondent Contact ROBERT E JAMES
Regulation Number866.2660
Classification Product Code
JSS  
Date Received11/30/1992
Decision Date 03/11/1993
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
-
-