I-STAT KAOLIN ACT TEST


Device Classification Name

activated whole blood clotting time

510(k) Number K023582
Device Name I-STAT KAOLIN ACT TEST
Original Applicant
I-STAT CORPORATION
104 windsor center dr.
east windsor, 
NJ 
08520

Original Contact paul vanderwerf
Regulation Number 864.7140
Classification Product Code
JBP  
Date Received 10/24/2002
Decision Date 09/08/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls