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 K894776
Device Name SENSITITRE INDOLE REAGENT
Applicant
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145 -1598
Applicant Contact GERALD L VEDAA
Correspondent
Radiometer America, Inc.
811 Sharon Dr.
Westlake,  OH  44145 -1598
Correspondent Contact GERALD L VEDAA
Regulation Number866.2660
Classification Product Code
JSS  
Date Received07/27/1989
Decision Date 08/31/1989
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
-
-