LOCI THYROID CALIBRATOR WITH MODEL RC610


Device Classification Name

calibrator, multi-analyte mixture

510(k) Number K081103
Device Name LOCI THYROID CALIBRATOR WITH MODEL RC610
Applicant
Siemens Healthcare Diagnostics Inc.
po box 6101
mailbox 514
newark, 
DE 
19714 -6101

Applicant Contact yuk-ting lewis
Correspondent
Siemens Healthcare Diagnostics Inc.
po box 6101
mailbox 514
newark, 
DE 
19714 -6101

Correspodent Contact yuk-ting lewis
Regulation Number 862.1150
Classification Product Code
JIX  
Date Received 04/18/2008
Decision Date 05/23/2008
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