ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY


codes

Device Classification Name

prostate-specific antigen (psa) for management of prostate cancers

510(k) Number K002376
Device Name ADVIA: CENTAUR AND ACS: 180 CPSA ASSAY
Original Applicant
BAYER CORP.
63 north st.
medfield, 
MA 
02052 -1688

Original Contact william j pignato
Regulation Number 866.6010
Classification Product Code
LTJ  
Date Received 08/04/2000
Decision Date 10/26/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Immunology

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No