‘RAPIDTEC’-5M-MULTIPLE DIP TEST


Device Classification Name

enzyme immunoassay, methadone

510(k) Number K023869
Device Name ‘RAPIDTEC’-5M-MULTIPLE DIP TEST
Original Applicant
AMERICAN BIO MEDICA CORP.
9110 red branch rd.
columbia, 
MD 
21045

Original Contact henry wells
Regulation Number 862.3620
Classification Product Code
DJR  
Subsequent Product Codes
DIG   JXM   LCM   LDJ  
Date Received 11/20/2002
Decision Date 04/30/2003
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No