VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL


Device Classification Name

plasma, coagulation control

510(k) Number K022046
Device Name VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEVEL 1,2,3,QUIKCOAG COAGULATION CONTROL
Original Applicant
VITAL SCIENTIFIC N.V.
one gateway center suite 411
newton, 
MA 
02458

Original Contact israel m stein
Regulation Number 864.5425
Classification Product Code
GGN  
Date Received 06/24/2002
Decision Date 07/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No