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 Acid, Lactic, Enzymatic Method
510(k) Number K112430
Device Name I-STAT LACTATE TEST/I-SAT CG4+CARTRIDGE
Applicant
Abbott Pont of Care, Inc.
400 College Rd. E.
Princton,  NJ  08540
Applicant Contact YUKO HARTLEY
Correspondent
Abbott Pont of Care, Inc.
400 College Rd. E.
Princton,  NJ  08540
Correspondent Contact YUKO HARTLEY
Regulation Number862.1450
Classification Product Code
KHP  
Date Received08/24/2011
Decision Date 12/20/2011
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
-
-