Cleared Special

R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL

K091433 · R&D Systems, Inc. · Hematology
Oct 2009
Decision
168d
Days
Class 2
Risk

About This 510(k) Submission

K091433 is an FDA 510(k) clearance for the R&D SYSTEMS TETIC-I PLUS HEMOTOLOGY CONTROL, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by R&D Systems, Inc. (Minneapolis, US). The FDA issued a Cleared decision on October 28, 2009, 168 days after receiving the submission on May 13, 2009. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K091433 FDA.gov
FDA Decision Cleared SESE
Date Received May 13, 2009
Decision Date October 28, 2009
Days to Decision 168 days
Submission Type Special
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code JPK — Mixture, Hematology Quality Control
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625