STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I


the company

Device Classification Name

enzyme immunoassay, barbiturate

510(k) Number K001976
Device Name STC BARBITURATES INTERCEPT MICRO-PLATE EIA, MODEL 1108I
Original Applicant
ORASURE TECHNOLOGIES, INC.
1745 eaton ave.
bethlehem, 
PA 
18018 -1799

Original Contact r. sam niedbala
Regulation Number 862.3150
Classification Product Code
DIS  
Date Received 06/29/2000
Decision Date 12/06/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No