FASTPACK FREE T4 IMMUNOASSAY


Device Classification Name

radioimmunoassay, free thyroxine

510(k) Number K030329
Device Name FASTPACK FREE T4 IMMUNOASSAY
Original Applicant
Qualigen, Inc.
2042 corte del nogal
carlsbad, 
CA 
92009 -1410

Original Contact dorothy deinzer
Regulation Number 862.1695
Classification Product Code
CEC  
Subsequent Product Code
JIX  
Date Received 01/31/2003
Decision Date 07/03/2003
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