ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM


Device Classification Name

system, hemoglobin, automated

510(k) Number K023561
Device Name ITC HGB PRO PROFESSIONAL HEMOGLOBIN TESTING SYSTEM
Original Applicant
INTERNATIONAL TECHNIDYNE CORP.
6 olsen ave.
edison, 
NJ 
08820

Original Contact john clay
Regulation Number 864.5620
Classification Product Code
GKR  
Date Received 10/23/2002
Decision Date 01/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Hematology

510k Review Panel

Hematology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls