DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691


Device Classification Name

radioimmunoassay, thyroid-stimulating hormone

510(k) Number K081074
Device Name DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691
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 862.1690
Classification Product Code
JLW  
Date Received 04/16/2008
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 Special
Reviewed by Third Party No

Combination Product

No

Recalls CDRH Recalls