Cleared Special

CBC-4K HEMATOLOGY CONTROL

K003874 · R&D Systems, Inc. · Hematology
Jan 2001
Decision
28d
Days
Class 2
Risk

About This 510(k) Submission

K003874 is an FDA 510(k) clearance for the CBC-4K 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 12, 2001, 28 days after receiving the submission on December 15, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K003874 FDA.gov
FDA Decision Cleared SESE
Date Received December 15, 2000
Decision Date January 12, 2001
Days to Decision 28 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