DFA RESPIRATORY VIRUS SCREENING & ID KIT


Device Classification Name

antisera, cf, influenza virus a, b, c

510(k) Number K022713
Device Name DFA RESPIRATORY VIRUS SCREENING & ID KIT
Original Applicant
DIAGNOSTIC HYBRIDS, INC.
350 west state st.
athens, 
OH 
45701

Original Contact james l brown
Regulation Number 866.3330
Classification Product Code
GNW  
Date Received 08/14/2002
Decision Date 12/18/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No