RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016


Device Classification Name

thin layer chromatography, barbiturate

510(k) Number K030211
Device Name RAPID BARBITURATE TEST STRIP AND TEST CARD, MODELS 7015 AND 7016
Original Applicant
ICN BIOMEDICALS, INC.
1429 rollins rd.
burlingame, 
CA 
94010

Original Contact charkes c.f. yu
Regulation Number 862.3150
Classification Product Code
DKX  
Date Received 01/21/2003
Decision Date 06/13/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No