FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON


Device Classification Name

instrument, coagulation

510(k) Number K021976
Device Name FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON
Original Applicant
VITAL SCIENTIFIC N.V.
one gateway center suite 411
newton, 
MA 
02458

Original Contact israel m stein
Regulation Number 864.5400
Classification Product Code
KQG  
Subsequent Product Code
JBT  
Date Received 06/17/2002
Decision Date 10/25/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No