THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE


Device Classification Name

antinuclear antibody (enzyme-labeled), antigen, controls

510(k) Number K024031
Device Name THE THERATEST EL-ANA PROFILES: ANTI-CENTROMERE
Original Applicant
THERATEST LABORATORIES, INC.
1111 n. main st.
lombard, 
IL 
60148

Original Contact marius teodorescu
Regulation Number 866.5100
Classification Product Code
LJM  
Date Received 12/06/2002
Decision Date 02/06/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No