BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,


Device Classification Name

enzyme immunoassay, cannabinoids

510(k) Number K080467
Device Name BIONEXA SINGLE AND MULTI-STRIP CASSETTE/DIPSTICK DOA SCREEN PANELS ( AMP, BAR, BZO, COC, MET, MTD, MOR, PCP, TCA, THC,
Applicant
APPLIED DNA TECHNOLOGIES, INC.
26251 verona place
mission viejo, 
CA 
92692

Applicant Contact feng yu-lee
Correspondent
APPLIED DNA TECHNOLOGIES, INC.
26251 verona place
mission viejo, 
CA 
92692

Correspodent Contact feng yu-lee
Regulation Number 862.3870
Classification Product Code
LDJ  
Subsequent Product Codes
DIO   DIS   DJC   DJG   DJR  
DKZ   DNK   JXM   LCM   LFG  
Date Received 02/21/2008
Decision Date 11/25/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No