Cleared Traditional

K943336 - RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE (FDA 510(k) Clearance)

K943336 · R&D Systems, Inc. · Hematology device
Dec 1994
Decision
153d
Days
Class 2
Risk

K943336 is an FDA 510(k) clearance for the RETIC CONTROL-H HEMATOLOGY CONTROL/MULTIPLE. This device is classified as 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 12, 1994, 153 days after receiving the submission on July 12, 1994.

This device falls under the Hematology FDA review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K943336 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1994
Decision Date December 12, 1994
Days to Decision 153 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code JPK — Mixture, Hematology Quality Control
Device Class Class II - Special Controls
CFR Regulation 21 CFR 864.8625