Cleared Special

R & D 3K RETIC

K003208 · R&D Systems, Inc. · Hematology
Nov 2000
Decision
25d
Days
Class 2
Risk

About This 510(k) Submission

K003208 is an FDA 510(k) clearance for the R & D 3K 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 November 7, 2000, 25 days after receiving the submission on October 13, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K003208 FDA.gov
FDA Decision Cleared SESE
Date Received October 13, 2000
Decision Date November 07, 2000
Days to Decision 25 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