ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS


Device Classification Name

ldl & vldl precipitation, hdl

510(k) Number K992029
Device Name ATAC DIRECT HDL CHOLESTEROL REAGENT AND ATAC HDL-C CALIBRATOR KITS
Applicant
ELAN DIAGNOSTICS
231 north puente st.
brea, 
CA 
92821

Applicant Contact wynn stocking
Correspondent
ELAN DIAGNOSTICS
231 north puente st.
brea, 
CA 
92821

Correspodent Contact wynn stocking
Regulation Number 862.1475
Classification Product Code
LBR  
Subsequent Product Code
JIS  
Date Received 06/16/1999
Decision Date 08/12/1999
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