Cleared Traditional

COULTER RETIC-C CELL CONTROL

K930119 · Coulter Electronics, Inc. · Hematology
Apr 1993
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K930119 is an FDA 510(k) clearance for the COULTER RETIC-C 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 April 5, 1993, 83 days after receiving the submission on January 12, 1993. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K930119 FDA.gov
FDA Decision Cleared SESE
Date Received January 12, 1993
Decision Date April 05, 1993
Days to Decision 83 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