DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS


Device Classification Name

enzyme linked immunoabsorbent assay, rubella

510(k) Number K073390
Device Name DIASORIN LIASON RUBELLA IGG ASSAY; DIASORIN LIAISON RUBELLA IGG TRI-CONTROLS
Applicant
DIASORIN, INC.
1951 northwestern ave.
stillwater, 
MN 
55082 -0285

Applicant Contact mari meyer
Correspondent
DIASORIN, INC.
1951 northwestern ave.
stillwater, 
MN 
55082 -0285

Correspodent Contact mari meyer
Regulation Number 866.3510
Classification Product Code
LFX  
Subsequent Product Code
JJX  
Date Received 12/03/2007
Decision Date 11/21/2008
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