Cleared Traditional

PX COULTER(R) CELL CONTROL

K912133 · Coulter Electronics, Inc. · Hematology
Jul 1991
Decision
64d
Days
Class 2
Risk

About This 510(k) Submission

K912133 is an FDA 510(k) clearance for the PX COULTER(R) CELL CONTROL, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Coulter Electronics, Inc. (Hialeah, US). The FDA issued a Cleared decision on July 17, 1991, 64 days after receiving the submission on May 14, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K912133 FDA.gov
FDA Decision Cleared SESE
Date Received May 14, 1991
Decision Date July 17, 1991
Days to Decision 64 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