N/T PROTEIN CONTROL LC


Device Classification Name

multi-analyte controls, all kinds (assayed)

510(k) Number K991704
Device Name N/T PROTEIN CONTROL LC
Applicant
DADE BEHRING, INC.
glasgow business community;
bldg. 500 mail box 514
p.o. box 6101, newark, 
DE 
19714 -6101

Applicant Contact rebecca s ayash
Correspondent
DADE BEHRING, INC.
glasgow business community;
bldg. 500 mail box 514
p.o. box 6101, newark, 
DE 
19714 -6101

Correspodent Contact rebecca s ayash
Regulation Number 862.1660
Classification Product Code
JJY  
Date Received 05/19/1999
Decision Date 06/25/1999
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

Category: Uncategorized