VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT


Device Classification Name

activated partial thromboplastin

510(k) Number K022021
Device Name VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT
Original Applicant
VITAL SCIENTIFIC N.V.
one gateway center suite 411
newton, 
MA 
02458

Original Contact israel m stein
Regulation Number 864.7925
Classification Product Code
GFO  
Date Received 06/20/2002
Decision Date 11/01/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No