• 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) | Registration & Listing | Adverse Events | Recalls | PMA | Classification | Standards | Inspections
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name enzyme immunoassay, gentamicin
510(k) Number K102699
Models 1P31, 1P31-01
Device Name ARCHITECT IGENTAMICIN REAGENTS; ARCHITECT IGENTAMICIN CALIBRATORS
Original Applicant
ABBOTT LABORATORIES
100 abbott park rd.
dept. 9v6 ap6c-2
abbott park,  IL  60064 6092
Original Contact judith wallach
Regulation Number862.3450
Classification Product Code
LCD  
Subsequent Product Code
DLJ  
Date Received09/20/2010
Decision Date 04/01/2011
Decision substantially equivalent - CLIA submission (CS)
Classification Advisory Committee Toxicology
Review Advisory Committee Toxicology
summary summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Expedited Review No
Combination Product No
-
-