QUANTA LITE H.PYLORI IGA ELISA


Device Classification Name

helicobacter pylori

510(k) Number K024334
Device Name QUANTA LITE H.PYLORI IGA ELISA
Original Applicant
INOVA DIAGNOSTICS, INC.
10180 scripps ranch blvd.
san diego, 
CA 
92131

Original Contact brys c myers
Regulation Number 866.3110
Classification Product Code
LYR  
Date Received 12/26/2002
Decision Date 03/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No