Cleared Traditional

COULTER ACT TRON CELL CONTROL

K971469 · Coulter Corp. · Hematology
Jun 1997
Decision
69d
Days
Class 2
Risk

About This 510(k) Submission

K971469 is an FDA 510(k) clearance for the COULTER ACT TRON CELL CONTROL, a Mixture, Hematology Quality Control (Class II — Special Controls, product code JPK), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on June 30, 1997, 69 days after receiving the submission on April 22, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K971469 FDA.gov
FDA Decision Cleared SESE
Date Received April 22, 1997
Decision Date June 30, 1997
Days to Decision 69 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