INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K022564
Device Name INSTANT-VIEW MULTI-DRUG SCREEN URINE TEST
Original Applicant
ALFA SCIENTIFIC DESIGNS, INC.
12330 stowe dr.
poway, 
CA 
92064

Original Contact naishu wang
Regulation Number 862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DIS   DJC   DJR   DOE  
DPK   JXM   LAF   LCM   LDJ  
Date Received 08/02/2002
Decision Date 08/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Special
Reviewed by Third Party No

Combination Product

No