VBL SERUM TROPONIN I TEST, MODEL 1001


Device Classification Name

immunoassay method, troponin subunit

510(k) Number K023505
Device Name VBL SERUM TROPONIN I TEST, MODEL 1001
Original Applicant
VANCOUVER BIOTECH LTD.
9418 lasaine ave.
northridge, 
CA 
91325

Original Contact robin j hellen, m.s.
Regulation Number 862.1215
Classification Product Code
MMI  
Date Received 10/18/2002
Decision Date 03/31/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No