FDA 510(k) Premarket Notification K081074: DIMENSION TSHL FLEX REAGENT CARTRIDGE AND TSH SAMPLE DILUENT WITH MODELS RF 612 AND KD691

Submission Details & Decision

Normalized public record details for 510(k) notification K081074.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K081074

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

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

Product Code

JLW

Decision Date

2008-05-23

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Special

Third Party Flag

Date Received

2008-04-16

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