D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT


Device Classification Name

antisera, conjugated fluorescent, cytomegalovirus

510(k) Number K081164
Device Name D3 DFA CYTOMEGALOVIRUS IMMEDIATE EARLY ANTIGEN IDENTIFICATION KIT
Applicant
DIAGNOSTIC HYBRIDS, INC.
1055 east state street
suite 100
athens, 
OH 
45701

Applicant Contact gail r goodrum
Correspondent
DIAGNOSTIC HYBRIDS, INC.
1055 east state street
suite 100
athens, 
OH 
45701

Correspodent Contact gail r goodrum
Regulation Number 866.3175
Classification Product Code
LIN  
Date Received 04/24/2008
Decision Date 06/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Microbiology

510k Review Panel

Microbiology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No