‘RAPIDTEC’ 5A MULTIPLE DIP TEST


Device Classification Name

enzyme immunoassay, amphetamine

510(k) Number K021114
Device Name ‘RAPIDTEC’ 5A MULTIPLE DIP TEST
Original Applicant
AMERICAN BIO MEDICA CORP.
9110 red branch rd.
columbia, 
MD 
21045

Original Contact henry wells
Regulation Number 862.3100
Classification Product Code
DKZ  
Subsequent Product Codes
DIO   DJG   LCM   LDJ  
Date Received 04/05/2002
Decision Date 07/23/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No