RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020


Device Classification Name

enzyme immunoassay, methadone

510(k) Number K023252
Device Name RAPID METHADONE TEST STRIP, MODEL 7019 & RAPID METHADONE TEST CARD, MODEL 7020
Original Applicant
ICN BIOMEDICALS, INC.
1429 rollins rd.
burlingame, 
CA 
94010

Original Contact charles c.f. yu
Regulation Number 862.3620
Classification Product Code
DJR  
Date Received 09/30/2002
Decision Date 11/22/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No