ELECSYS INSULIN CALSET


Device Classification Name

calibrator, primary

510(k) Number K001906
Device Name ELECSYS INSULIN CALSET
Original Applicant
ROCHE DIAGNOSTICS CORP.
9115 hague rd.
p.o. box 50457
indianapolis, 
IN 
46250 -0457

Original Contact kay a taylor
Regulation Number 862.1150
Classification Product Code
JIS  
Date Received 06/22/2000
Decision Date 07/13/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No