Cleared Special

DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108

K081992 · Siemens Healthcare Diagnostics, Inc. · Toxicology
Aug 2008
Decision
22d
Days
Class 2
Risk

About This 510(k) Submission

K081992 is an FDA 510(k) clearance for the DIMENSION VISTA CSAE FLEX REGENT CARTRIDGE, MODEL K4108, a Cyclosporine (Class II — Special Controls, product code MKW), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on August 5, 2008, 22 days after receiving the submission on July 14, 2008. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.1235.

Submission Details

510(k) Number K081992 FDA.gov
FDA Decision Cleared SESE
Date Received July 14, 2008
Decision Date August 05, 2008
Days to Decision 22 days
Submission Type Special
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code MKW — Cyclosporine
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.1235

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