IMMUNOCARD STAT! E. COLI O157 PLUS


Device Classification Name

antigens, all types, escherichia coli

510(k) Number K023599
Device Name IMMUNOCARD STAT! E. COLI O157 PLUS
Original Applicant
MERIDIAN BIOSCIENCE, INC.
3471 river hills dr.
cincinnati, 
OH 
45244

Original Contact susan rolih
Regulation Number 866.3255
Classification Product Code
GMZ  
Date Received 10/28/2002
Decision Date 01/03/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No