Cleared Traditional

DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440

K082030 · Siemens Healthcare Diagnostics, Inc. · Toxicology
Aug 2008
Decision
36d
Days
Class 2
Risk

About This 510(k) Submission

K082030 is an FDA 510(k) clearance for the DIMENSION VISTA CSAE CALIBRATOR, MODEL KC440, a Calibrators, Drug Specific (Class II — Special Controls, product code DLJ), submitted by Siemens Healthcare Diagnostics, Inc. (Newark, US). The FDA issued a Cleared decision on August 22, 2008, 36 days after receiving the submission on July 17, 2008. This device falls under the Toxicology review panel. Regulated under 21 CFR 862.3200.

Submission Details

510(k) Number K082030 FDA.gov
FDA Decision Cleared SESE
Date Received July 17, 2008
Decision Date August 22, 2008
Days to Decision 36 days
Submission Type Traditional
Review Panel Toxicology (TX)
Summary Summary PDF

Device Classification

Product Code DLJ — Calibrators, Drug Specific
Device Class Class II — Special Controls
CFR Regulation 21 CFR 862.3200

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