MODIFICATION TO PROFILE -II


definition

Device Classification Name

enzyme immunoassay, phencyclidine

510(k) Number K002776
Device Name MODIFICATION TO PROFILE -II
Original Applicant
MEDTOX DIAGNOSTICS, INC.
1238 anthony rd.
burlington, 
NC 
27215

Original Contact michael turanchik
Regulation Number 862.3100
Classification Product Code
LCM  
Subsequent Product Codes
DIO   DJG   DKE   DKZ  
Date Received 09/06/2000
Decision Date 09/28/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Special
Reviewed by Third Party No

Combination Product

No