ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS


definition

Device Classification Name

urease and glutamic dehydrogenase, urea nitrogen

510(k) Number K000958
Device Name ATAC PAK BUN REAGENT AND ATAC CALIBRATOR KITS
Original Applicant
ELAN HOLDINGS, INC.
231 north puente st.
brea, 
CA 
92821

Original Contact wynn stoking
Regulation Number 862.1770
Classification Product Code
CDQ  
Date Received 03/24/2000
Decision Date 05/24/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No