VIDAS TESTOSTERONE (TES), MODEL 30 418


Device Classification Name

radioimmunoassay, testosterones and dihydrotestosterone

510(k) Number K021326
Device Name VIDAS TESTOSTERONE (TES), MODEL 30 418
Original Applicant
BIOMERIEUX, INC.
595 anglum rd.
hazelwood, 
MO 
63042

Original Contact kelly rowland
Regulation Number 862.1680
Classification Product Code
CDZ  
Subsequent Product Codes
JIS   JJX  
Date Received 04/26/2002
Decision Date 07/18/2002
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

Category: Uncategorized