QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA


Device Classification Name

antibodies, anti-actin, anti-smooth muscle

510(k) Number K021648
Device Name QUANTA LITE ACTIN (ANTI-SMOOTH MUSCLE) ELISA
Original Applicant
INOVA DIAGNOSTICS, INC.
10180 scripps ranch blvd.
san diego, 
CA 
92131

Original Contact brys c myers
Regulation Number 866.5120
Classification Product Code
NJF  
Date Received 05/20/2002
Decision Date 09/20/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No