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

Premarket Approval (PMA)
  • 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 Biologics Premarket Approvals (PMAs) Back to Search Results
Note: this medical device record is a supplement.
 
Device IMx Core-M Assay
Classification Namesystem, identification, hepatitis b antigen
Generic Nameidentification system for hepatitis b antigen
Applicant
Abbott Laboratories
abbott park buckley road and waukegan road
North Chicago , IL 60064 
  
PMA NumberBP900002
Supplement NumberS008
Date Received01/13/2004
Decision Date02/06/2004
Decision Approved
Product Code
KSJ[ Registered Establishments with KSJ ]
Advisory Committee Hematology
Supplement Type30-Day Notice
Expedited Review Granted? No
Third Party Review Elligble? No
Combination ProductNo
-
-