ALBUMIN COBALT BINDING TEST (ACB TEST)


Device Classification Name

test, albumin cobalt binding

510(k) Number K023824
Device Name ALBUMIN COBALT BINDING TEST (ACB TEST)
Original Applicant
ISCHEMIA TECHNOLOGIES, INC.
4600 west 60th ave.
arvada, 
CO 
80003

Original Contact peter crosby
Regulation Number 862.1215
Classification Product Code
NJV  
Date Received 11/18/2002
Decision Date 02/14/2003
Decision

se – with limitations

(SESU)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No