Cleared Traditional

HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S

K072268 · R&D Systems, Inc. · Hematology
Nov 2007
Decision
97d
Days
Class 2
Risk

About This 510(k) Submission

K072268 is an FDA 510(k) clearance for the HC WBC HEMATOLOGY CONTROL, MODEL: WBC00S, 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 November 20, 2007, 97 days after receiving the submission on August 15, 2007. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K072268 FDA.gov
FDA Decision Cleared SESE
Date Received August 15, 2007
Decision Date November 20, 2007
Days to Decision 97 days
Submission Type Traditional
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