Cleared Special

CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04

K072096 · R&D Systems, Inc. · Hematology
Aug 2007
Decision
20d
Days
Class 2
Risk

About This 510(k) Submission

K072096 is an FDA 510(k) clearance for the CBC-5D PLUS RETICS HEMATOLOGY CONTROL, MODELS: 5DR03, 5DR04, 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 August 20, 2007, 20 days after receiving the submission on July 31, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K072096 FDA.gov
FDA Decision Cleared SESE
Date Received July 31, 2007
Decision Date August 20, 2007
Days to Decision 20 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