MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL


Device Classification Name

urinalysis controls (assayed and unassayed)

510(k) Number K103387
Device Name MISSION LIQUID URINE CONTROL, MISSION LIQUID DIPTUBE URINE CONTROL, MISSION DRY STRIP URINE CONTROL
Applicant
ACON LABORATORIES, INC.
10125 mesa rim rd.
san diego, 
CA 
92121

Applicant Contact richard lenart
Correspondent
ACON LABORATORIES, INC.
10125 mesa rim rd.
san diego, 
CA 
92121

Correspodent Contact richard lenart
Regulation Number 862.1660
Classification Product Code
JJW  
Date Received 11/18/2010
Decision Date 02/02/2011
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No