LIAISON N-TACT PTH

Device Classification Name

radioimmunoassay, parathyroid hormone

510(k) Number K033426
Device Name LIAISON N-TACT PTH
Applicant
DIASORIN, INC.
1951 northwestern ave.
p.o. box 285
stillwater, 
MN 
55082

Applicant Contact david m ikeda
Correspondent
DIASORIN, INC.
1951 northwestern ave.
p.o. box 285
stillwater, 
MN 
55082

Correspodent Contact david m ikeda
Regulation Number 862.1545
Classification Product Code
CEW  
Subsequent Product Code
JJX  
Date Received 10/27/2003
Decision Date 02/12/2004
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No