RAPID TOX CUP


Device Classification Name

high pressure liquid chromatography, methamphetamine

510(k) Number K073078
Device Name RAPID TOX CUP
Applicant
AMERICAN BIO MEDICA CORP.
603 heron dr.
unit 3
logan township, 
NJ 
08085

Applicant Contact rich reilly
Correspondent
AMERICAN BIO MEDICA CORP.
603 heron dr.
unit 3
logan township, 
NJ 
08085

Correspodent Contact rich reilly
Regulation Number 862.3610
Classification Product Code
LAG  
Subsequent Product Codes
DIO   DJG   DJR   DKE   DKZ  
JXM   JXN   LCM   LFI  
Date Received 10/31/2007
Decision Date 05/30/2008
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