FASTPACK TESTOSTERONE CALIBRATOR


Device Classification Name

calibrator, secondary

510(k) Number K022533
Device Name FASTPACK TESTOSTERONE CALIBRATOR
Original Applicant
Qualigen, Inc.
2042 corte del nogal
carlsbad, 
CA 
92009

Original Contact dorothy deinzer
Regulation Number 862.1150
Classification Product Code
JIT  
Date Received 07/31/2002
Decision Date 09/30/2002
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

Type Abbreviated
Reviewed by Third Party No

Combination Product

No