AESKULISA ANA HEP-2, REF 30-7115US


Device Classification Name

antinuclear antibody, antigen, control

510(k) Number K081104
Device Name AESKULISA ANA HEP-2, REF 30-7115US
Applicant
AESKU.DIAGNOSTICS
mikroforum ring 2
wendelsheim, 

DE

d-55234

Applicant Contact jim radford
Regulation Number 866.5100
Classification Product Code
LKJ  
Date Received 04/18/2008
Decision Date 05/02/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

statement

statement

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party Yes

Combination Product

No