Cleared Special

K081300 - DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE
(FDA 510(k) Clearance)

K081300 · Siemens Healthcare Diagnostics · Chemistry

Jul 2008

Decision

55d

Days

Class 1

Risk

K081300 is an FDA 510(k) clearance for the DIMENSION VISTA HDLC FLEX REAGENT CARTRIDGE. This device is classified as a Colorimetric Method, Lipoproteins (Class I — General Controls, product code JHM).

Submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on July 2, 2008, 55 days after receiving the submission on May 8, 2008.

This device falls under the Chemistry FDA review panel. Regulated under 21 CFR 862.1475.

Submission Details

510(k) Number	K081300 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 08, 2008
Decision Date	July 02, 2008
Days to Decision	55 days
Submission Type	Special
Review Panel	Chemistry (CH)
Summary	Summary PDF