Cleared Special

R&D CBC-XE HEMATOLOGY CONTROL

K042094 · R&D Systems, Inc. · Hematology
Sep 2004
Decision
29d
Days
Class 2
Risk

About This 510(k) Submission

K042094 is an FDA 510(k) clearance for the R&D CBC-XE 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 September 1, 2004, 29 days after receiving the submission on August 3, 2004. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K042094 FDA.gov
FDA Decision Cleared SESE
Date Received August 03, 2004
Decision Date September 01, 2004
Days to Decision 29 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