FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900


the company

Device Classification Name

radioimmunoassay, testosterones and dihydrotestosterone

510(k) Number K001086
Device Name FREE TESTOSTERONE ENZYME IMMUNOASSAY, MODEL DSL-10-4900
Original Applicant
DIAGNOSTIC SYSTEMS LABORATORIES, INC.
445 medical center blvd.
webster, 
TX 
77598

Original Contact john class
Regulation Number 862.1680
Classification Product Code
CDZ  
Date Received 04/04/2000
Decision Date 05/18/2000
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Immunology

Type Traditional
Reviewed by Third Party No

Combination Product

No