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 glucose oxidase, glucose
510(k) Number K223755
Device Name i-STAT G cartridge with the i-STAT 1 System
Applicant
Abbott Point of Care Inc.
400 College Road Test
Princeton,  NJ  08540
Applicant Contact Mojgan Soleimani
Correspondent
Abbott Point of Care Inc.
400 College Road East
Princeton,  NJ  08540
Correspondent Contact Mojgan Soleimani
Regulation Number862.1345
Classification Product Code
CGA  
Date Received12/15/2022
Decision Date 09/11/2023
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
-
-