Cleared Special

R&D 5D RETIC HEMATOLOGY CONTROL

K130962 · R&D Systems, Inc. · Hematology
Jul 2013
Decision
107d
Days
Class 2
Risk

About This 510(k) Submission

K130962 is an FDA 510(k) clearance for the R&D 5D RETIC 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 July 24, 2013, 107 days after receiving the submission on April 8, 2013. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K130962 FDA.gov
FDA Decision Cleared SESE
Date Received April 08, 2013
Decision Date July 24, 2013
Days to Decision 107 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