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 Fluorescent Immunoassay, Tobramycin
510(k) Number K952568
Device Name BECKMAN ARRAY TOBRAMYCIN (TOB) REAGENT
Applicant
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
Box 8000
Brea,  CA  92821
Applicant Contact DON W HART
Correspondent
Beckman Instruments, Inc.
200 S. Kraemer Blvd.
Box 8000
Brea,  CA  92821
Correspondent Contact DON W HART
Regulation Number862.3900
Classification Product Code
LCR  
Date Received06/05/1995
Decision Date 08/08/1995
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
-
-