ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01


Device Classification Name

anti-dna antibody, antigen and control

510(k) Number K072393
Device Name ELIA DSDNA IMMUNOASSAY, MODEL 14-5500-01, ELIA ANA CONTROL, MODEL 83-1004-01
Applicant
PHADIA US INC.
4169 commercial ave.
portage, 
MI 
49002

Applicant Contact martin r mann
Correspondent
PHADIA US INC.
4169 commercial ave.
portage, 
MI 
49002

Correspodent Contact martin r mann
Regulation Number 866.5100
Classification Product Code
LSW  
Subsequent Product Code
JJY  
Date Received 08/27/2007
Decision Date 12/07/2007
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No