TRUCATH.IP


Device Classification Name

lambda, rhodamine, antigen, antiserum, control

510(k) Number K023368
Device Name TRUCATH.IP
Original Applicant
AORTECH CRITICAL CARE LTD.
phoenix crescent
strathclyde business park
bellshill, lanarkshire, 

GB

ml4 3nj

Original Contact paul burns
Regulation Number 866.5550
Classification Product Code
DFG  
Date Received 10/08/2002
Decision Date 10/28/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Cardiovascular

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No