STARTOX DRUG OF ABUSE SCREENING TEST (4)


Device Classification Name

thin layer chromatography, metamphetamine

510(k) Number K022388
Device Name STARTOX DRUG OF ABUSE SCREENING TEST (4)
Original Applicant
STARPLEX SCIENTIFIC, INC.
163 cabot st.
beverly, 
MA 
01915

Original Contact fran white
Regulation Number 862.3610
Classification Product Code
DJC  
Subsequent Product Codes
DIO   DJG   LDJ  
Date Received 07/23/2002
Decision Date 02/27/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No