MODIFICATION TO AESKULISA DS DNA G


Device Classification Name

anti-dna antibody, antigen and control

510(k) Number K081251
Device Name MODIFICATION TO AESKULISA DS DNA G
Applicant
AESKU.DIAGNOSTICS
mikroforum ring 2
wendelsheim, 

DE

d-55234

Applicant Contact sascha pfeiffer
Regulation Number 866.5100
Classification Product Code
LSW  
Date Received 05/02/2008
Decision Date 05/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

summary

summary

FDA Review Decision Summary
Type Special
Reviewed by Third Party Yes

Combination Product

No