Cleared Traditional

K993496 - RETIC-QUINOX
(FDA 510(k) Clearance)

K993496 · Hematronix, Inc. · Hematology
Nov 1999
Decision
46d
Days
Class 2
Risk

K993496 is an FDA 510(k) clearance for the RETIC-QUINOX, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Hematronix, Inc. (Benicia, US). The FDA issued a Cleared decision on November 30, 1999, 46 days after receiving the submission on October 15, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K993496 FDA.gov
FDA Decision Cleared SESE
Date Received October 15, 1999
Decision Date November 30, 1999
Days to Decision 46 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