FDA 510(k) Premarket Notification K081992: DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108

Submission Details & Decision

Normalized public record details for 510(k) notification K081992.

Source Dataset

FDA 510(k) Premarket Notifications

510(k) Number

K081992

Applicant / Sponsor

Siemens Healthcare Diagnostics, Inc.

Device Name

DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108

Product Code

MKW

Decision Date

2008-08-05

Decision / Status

Substantially Equivalent (SESE)

Advisory Committee

Clinical Chemistry (CH)

Clearance Type

Special

Third Party Flag

Date Received

2008-07-14

Related Establishments / Registrations

Siemens Healthcare Diagnostics Inc. Registration: 1219913 View Registration
ABBOTT LABORATORIES Registration: 1415939 View Registration
Fujirebio Diagnostics, Inc. Registration: 1643621 View Registration
Siemens Healthcare Diagnostics Inc. Registration: 2432235 View Registration
SIEMENS HEALTHCARE DIAGNOSTICS INC. Registration: 2517506 View Registration
Fujirebio Diagnostics, Inc. Registration: 2521625 View Registration
ABBOTT LABORATORIES Registration: 3005333358 View Registration
INPECO SA Registration: 3010825766 View Registration
Microgenics Corporation Registration: 3010939897 View Registration
ROCHE DIAGNOSTICS GMBH Registration: 9610126 View Registration

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