STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541


the company

Device Classification Name

enzyme immunoassay, phencyclidine

510(k) Number K000399
Device Name STC PCP INTERCEPT MICRO-PLATE EIA, MODEL 11541
Original Applicant
ORASURE TECHNOLOGIES, INC.
1745 eaton ave.
bethlehem, 
PA 
18018 -1799

Original Contact r. sam neidbala
Regulation Number 862.3100
Classification Product Code
LCM  
Date Received 02/07/2000
Decision Date 05/15/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Toxicology

510k Review Panel

Toxicology

Type Traditional
Reviewed by Third Party No

Combination Product

No