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 test, time, prothrombin
510(k) Number K020355
Device Name I-STAT PROTHROMBIN TIME TEST
Applicant
I-STAT CORPORATION
104 WINDSOR CENTER DR.
EAST WINDSOR,  NJ  08540
Applicant Contact PAUL VANDERERF
Correspondent
I-STAT CORPORATION
104 WINDSOR CENTER DR.
EAST WINDSOR,  NJ  08540
Correspondent Contact PAUL VANDERERF
Regulation Number864.7750
Classification Product Code
GJS  
Date Received02/04/2002
Decision Date 05/14/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
-
-