Cleared Traditional

PENTRA 5D

K003534 · R&D Systems, Inc. · Hematology
Dec 2000
Decision
15d
Days
Class 2
Risk

About This 510(k) Submission

K003534 is an FDA 510(k) clearance for the PENTRA 5D, 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 December 1, 2000, 15 days after receiving the submission on November 16, 2000. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K003534 FDA.gov
FDA Decision Cleared SESE
Date Received November 16, 2000
Decision Date December 01, 2000
Days to Decision 15 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