MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K021381
Device Name MODIFICATION TO N/T RHEUMATOLOGY CONTROLS SL 1 & 2
Original Applicant
DADE BEHRING, INC.
514 gbc dr.
newark, 
DE 
19702

Original Contact donna a wolf
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 05/01/2002
Decision Date 06/10/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No