Cleared Special

R&D CBC-4K PLUS RETICS HEMATOLOGY CONTROL

K051339 · R&D Systems, Inc. · Hematology
Jul 2005
Decision
50d
Days
Class 2
Risk

About This 510(k) Submission

K051339 is an FDA 510(k) clearance for the R&D CBC-4K PLUS RETICS 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 12, 2005, 50 days after receiving the submission on May 23, 2005. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K051339 FDA.gov
FDA Decision Cleared SESE
Date Received May 23, 2005
Decision Date July 12, 2005
Days to Decision 50 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