Cleared Traditional

COULTER LINEARITY CONTROL

K955334 · Coulter Corp. · Hematology
Feb 1996
Decision
80d
Days
Class 2
Risk

About This 510(k) Submission

K955334 is an FDA 510(k) clearance for the COULTER LINEARITY 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 February 8, 1996, 80 days after receiving the submission on November 20, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K955334 FDA.gov
FDA Decision Cleared SESE
Date Received November 20, 1995
Decision Date February 08, 1996
Days to Decision 80 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