AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED


Device Classification Name

system, multipurpose for in vitro coagulation studies

510(k) Number K021162
Device Name AMAX DENSITY COAGULATION ANALYZER, AMAX DENSTINY COAGULATION ANALYZER-EU, AMAX DESTINY COAGULATION ANALYZER-REFURBISHED
Original Applicant
SIGMA DIAGNOSTICS, INC.
545 south ewing ave.
st. louis, 
MO 
63103

Original Contact william r gilbert ii
Regulation Number 864.5425
Classification Product Code
JPA  
Date Received 04/11/2002
Decision Date 08/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No