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 Analyzer, Enzyme, For Clinical Use
510(k) Number K944731
Device Name ABBOTT IMX 2 ANALYZER
Applicant
ABBOTT LABORATORIES
NORTH CHICAGO,  IL  60064
Applicant Contact MARY SPIEWAK
Correspondent
ABBOTT LABORATORIES
NORTH CHICAGO,  IL  60064
Correspondent Contact MARY SPIEWAK
Regulation Number862.2500
Classification Product Code
JJI  
Date Received09/12/1994
Decision Date 12/19/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Toxicology
Type Traditional
Reviewed by Third Party No
Combination Product No
-
-