BIOCHECK TESTOSTERONE EIA, MODEL BC-1115


Device Classification Name

radioimmunoassay, testosterones and dihydrotestosterone

510(k) Number K002294
Device Name BIOCHECK TESTOSTERONE EIA, MODEL BC-1115
Original Applicant
BIOCHECK, INC.
9418 lasaine ave.
northridge, 
CA 
91325

Original Contact robin j hellen
Regulation Number 862.1680
Classification Product Code
CDZ  
Date Received 07/27/2000
Decision Date 10/02/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

Type Traditional
Reviewed by Third Party No

Combination Product

No