Cleared Special

R & D SYSTEMS XERET HEMATOLOGY CONTROL

K100050 · R&D Systems, Inc. · Hematology
Jan 2010
Decision
21d
Days
Class 2
Risk

About This 510(k) Submission

K100050 is an FDA 510(k) clearance for the R & D SYSTEMS XERET HEMATOLOGY 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 January 29, 2010, 21 days after receiving the submission on January 8, 2010. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K100050 FDA.gov
FDA Decision Cleared SESE
Date Received January 08, 2010
Decision Date January 29, 2010
Days to Decision 21 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