ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE


Device Classification Name

enzyme immunoassay, barbiturate

510(k) Number K023946
Device Name ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST CARD, ACON ONE STEP MULTI-DRUG MULTI-LINE SCREEN TEST DEVICE
Original Applicant
ACON LABORATORIES, INC.
4108 sorrento valley blvd.
san diego, 
CA 
92121

Original Contact edward tung
Regulation Number 862.3150
Classification Product Code
DIS  
Subsequent Product Codes
DJC   DJG   DJR   JXM   LFG  
Date Received 11/27/2002
Decision Date 02/05/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No