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 Biosensor, Immunoassay, Cpk Or Isoenzymes
510(k) Number K051433
Device Name I-STAT CREATINE KINASE MB (CK-MB)
Applicant
I-STAT CORPORATION
104 WINDSOR CENTER DRIVE
EAST WINDSOR,  NJ  08520
Applicant Contact SUE KENT
Correspondent
I-STAT CORPORATION
104 WINDSOR CENTER DRIVE
EAST WINDSOR,  NJ  08520
Correspondent Contact SUE KENT
Regulation Number862.1215
Classification Product Code
MYT  
Subsequent Product Code
MMI  
Date Received06/01/2005
Decision Date 12/15/2005
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
Recalls CDRH Recalls
-
-