Cleared Traditional

R & D 4K RETIC

K010470 · R&D Systems, Inc. · Hematology
May 2001
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K010470 is an FDA 510(k) clearance for the R & D 4K RETIC, 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 May 11, 2001, 80 days after receiving the submission on February 20, 2001. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K010470 FDA.gov
FDA Decision Cleared SESE
Date Received February 20, 2001
Decision Date May 11, 2001
Days to Decision 80 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