ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE


Device Classification Name

radioimmunoassay, tricyclic antidepressant drugs

510(k) Number K021526
Device Name ACON TCA ONE STEP TRICYCLIC ANTIDEPRESSANT TEST STRIP AND DEVICE
Original Applicant
ACON LABORATORIES, INC.
4108 sorrento valley blvd.
san diego, 
CA 
92121

Original Contact edward tung
Regulation Number 862.3910
Classification Product Code
LFG  
Date Received 05/10/2002
Decision Date 07/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No