DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD


Device Classification Name

radioimmunoassay, free thyroxine

510(k) Number K073604
Device Name DIMENSION EXL WITH LM CLINICAL CHEMISTRY SYSTEM, DIMENSION FT4L FLEX REAGENT CARTRIDGE, AND LOCI THYROID CALIBRATOR, MOD
Applicant
DADE BEHRING, INC.
500 gbc dr, mailstop 514
newark, 
DE 
19714 -6101

Applicant Contact yuk-ting lewis
Correspondent
DADE BEHRING, INC.
500 gbc dr, mailstop 514
newark, 
DE 
19714 -6101

Correspodent Contact yuk-ting lewis
Regulation Number 862.1695
Classification Product Code
CEC  
Subsequent Product Codes
JIT   JJE  
Date Received 12/21/2007
Decision Date 03/13/2008
Decision

substantially equivalent

(SESE)

Regulation Medical Specialty

Clinical Chemistry

510k Review Panel

Clinical Chemistry

summary

summary

FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls