EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS


Device Classification Name

glucose oxidase, glucose

510(k) Number K021781
Device Name EXCELSIOR 3UL TEST STRIPS, FOR USE WITH THE HOME DIAGNOSTICS, INC. PRESTIGE LX AND IQ BLOOD GLUCOSE SYSTEMS
Original Applicant
CHAY MEDICAL, LLC.
3257 route 128
calistoga, 
CA 
94515

Original Contact stephen c pearson
Regulation Number 862.1345
Classification Product Code
CGA  
Date Received 05/30/2002
Decision Date 08/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

statement

statement

Type Traditional
Reviewed by Third Party No

Combination Product

No