QUANTA PLEX ENA PROFILE 4


Device Classification Name

extractable antinuclear antibody, antigen and control

510(k) Number K011140
Device Name QUANTA PLEX ENA PROFILE 4
Original Applicant
INOVA DIAGNOSTICS, INC.
10180 scripps ranch blvd.
san diego, 
CA 
92131

Original Contact brys c myers
Regulation Number 866.5100
Classification Product Code
LLL  
Date Received 04/13/2001
Decision Date 07/27/2001
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No