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 Fluorescence Polarization Immunoassay, Tobramycin
510(k) Number K843828
Device Name COBAS REAGENTS FOR TOBRAMYCIN & CALIBRA
Applicant
Roche Diagnostic Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Correspondent
Roche Diagnostic Systems, Inc.
803 N. Front St. Suite 3
Mchenry,  IL  60050
Regulation Number862.3900
Classification Product Code
LFW  
Date Received09/28/1984
Decision Date 02/01/1985
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-