STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421


definition

Device Classification Name

enzyme immunoassay, methadone

510(k) Number K002010
Device Name STC METHADONE INTERCEPT MICRO-PLATE EIA, MODEL 11421
Original Applicant
ORASURE TECHNOLOGIES, INC.
1745 eaton ave.
bethlehem, 
PA 
18018 -1799

Original Contact r. sam niedbala
Regulation Number 862.3620
Classification Product Code
DJR  
Date Received 07/03/2000
Decision Date 11/29/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No