MAS DIABETES CONTROL – LYOPHILIZED ASSAYED DIABETES CONTROL


Device Classification Name

single (specified) analyte controls (assayed and unassayed)

510(k) Number K023307
Device Name MAS DIABETES CONTROL – LYOPHILIZED ASSAYED DIABETES CONTROL
Original Applicant
MEDICAL ANALYSIS SYSTEMS, INC.
5300 adolfo rd.
camarillo, 
CA 
93012

Original Contact penny m layman
Regulation Number 862.1660
Classification Product Code
JJX  
Date Received 10/03/2002
Decision Date 10/31/2002
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