Cleared Traditional

IMMUNO-TROL CONTROL CELLS

K984216 · Coulter Corp. · Hematology
Mar 1999
Decision
112d
Days
Class 2
Risk

About This 510(k) Submission

K984216 is an FDA 510(k) clearance for the IMMUNO-TROL CONTROL CELLS, 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 March 16, 1999, 112 days after receiving the submission on November 24, 1998. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K984216 FDA.gov
FDA Decision Cleared SESE
Date Received November 24, 1998
Decision Date March 16, 1999
Days to Decision 112 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