THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES


codes

Device Classification Name

system, multipurpose for in vitro coagulation studies

510(k) Number K002177
Device Name THROMBELASTOGRAPH COAGULATION ANALYZER TEG-5000 SERIES
Original Applicant
HAEMOSCOPE CORP.
7855 gross point rd.
suite g4
skokie, 
IL 
60077

Original Contact eli cohen
Regulation Number 864.5425
Classification Product Code
JPA  
Date Received 07/19/2000
Decision Date 09/14/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls