MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS CONTROL


Device Classification Name

urinalysis controls (assayed and unassayed)

510(k) Number K023928
Device Name MAS UA CONTROL LIQUID ASSAYED URINALYSIS CONTROL, DADE ASSAYED URINALYSIS 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
JJW  
Date Received 11/25/2002
Decision Date 12/11/2002
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