Cleared Traditional

K092283 - DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG
(FDA 510(k) Clearance)

K092283 · Siemens Healthcare Diagnostics · Immunology

Oct 2009

Decision

84d

Days

Class 2

Risk

K092283 is an FDA 510(k) clearance for the DIMENSION VISTA IMMUNOGLOBULIN IGG SUBCLASSS 1FLEX REAGENT CARTRIDGE, DIMENSION VISTA IMMUNOGLOBULIN IGG, a Igg (gamma Chain Specific), Antigen, Antiserum, Control (Class II — Special Controls, product code DFZ), submitted by Siemens Healthcare Diagnostics (Newark, US). The FDA issued a Cleared decision on October 21, 2009, 84 days after receiving the submission on July 29, 2009. This device falls under the Immunology review panel. Regulated under 21 CFR 866.5510.

Submission Details

510(k) Number	K092283 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 29, 2009
Decision Date	October 21, 2009
Days to Decision	84 days
Submission Type	Traditional
Review Panel	Immunology (IM)
Summary	Summary PDF