FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY


Device Classification Name

radioimmunoassay, testosterones and dihydrotestosterone

510(k) Number K021972
Device Name FASTPACK TOTAL TESTOSTERONE IMMUNOASSAY
Original Applicant
Qualigen, Inc.
2042 corte del nogal
carlsbad, 
CA 
92009

Original Contact dorothy deinzer
Regulation Number 862.1680
Classification Product Code
CDZ  
Date Received 06/17/2002
Decision Date 08/21/2002
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

Recalls CDRH Recalls