Cleared Traditional

4C PLUS COULTER CELL CONTROL

K955016 · Coulter Corp. · Hematology
Jan 1996
Decision
89d
Days
Class 2
Risk

About This 510(k) Submission

K955016 is an FDA 510(k) clearance for the 4C PLUS COULTER 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 January 30, 1996, 89 days after receiving the submission on November 2, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K955016 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1995
Decision Date January 30, 1996
Days to Decision 89 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