TRI-COUNT 20


Device Classification Name

mixture, hematology quality control

510(k) Number K960471
Device Name TRI-COUNT 20
Applicant
HEMATRONIX, INC.
524 stone rd.
suite a
benicia, 
CA 
94510

Applicant Contact james d lapicola
Correspondent
HEMATRONIX, INC.
524 stone rd.
suite a
benicia, 
CA 
94510

Correspodent Contact james d lapicola
Regulation Number 864.8625
Classification Product Code
JPK  
Date Received 02/01/1996
Decision Date 03/20/1996
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Category: Uncategorized