ST AIA-PACK TESTOSTERONE ASSAY


Device Classification Name

radioimmunoassay, testosterones and dihydrotestosterone

510(k) Number K023091
Device Name ST AIA-PACK TESTOSTERONE ASSAY
Original Applicant
TOSOH MEDICS, INC.
347 oyster point blvd.,
suite 201
san francisco, 
CA 
94080

Original Contact lois nakayama
Regulation Number 862.1680
Classification Product Code
CDZ  
Date Received 09/17/2002
Decision Date 12/17/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Traditional
Reviewed by Third Party No

Combination Product

No