N PROTEIN STANDARD SL


definition

Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K002804
Device Name N PROTEIN STANDARD SL
Original Applicant
DADE BEHRING, INC.
glasgow business community;
bldg. 500 mail box 514
p.o. box 6101, newark, 
DE 
19714 -6101

Original Contact rebecca s ayash
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 09/08/2000
Decision Date 10/05/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No