INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST


Device Classification Name

enzyme immunoassay, propoxyphene

510(k) Number K022915
Device Name INSTANT-VIEW PROPOXYPHENE (PPX) URINE TEST
Original Applicant
ALFA SCIENTIFIC DESIGNS, INC.
12330 stowe dr.
poway, 
CA 
92064

Original Contact naishu wang
Regulation Number 862.3700
Classification Product Code
JXN  
Date Received 09/03/2002
Decision Date 11/29/2002
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