Cleared Traditional

COULTER POSITIVE CONTROL CELLS

K894651 · Coulter Corp. · Hematology
Sep 1989
Decision
51d
Days
Class 2
Risk

About This 510(k) Submission

K894651 is an FDA 510(k) clearance for the COULTER POSITIVE CONTROL CELLS, a Control, White-cell (Class II — Special Controls, product code GGL), submitted by Coulter Corp. (Hialeah, US). The FDA issued a Cleared decision on September 13, 1989, 51 days after receiving the submission on July 24, 1989. This device falls under the Hematology review panel. Regulated under 21 CFR 864.8625.

Submission Details

510(k) Number K894651 FDA.gov
FDA Decision Cleared SESE
Date Received July 24, 1989
Decision Date September 13, 1989
Days to Decision 51 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

Product Code GGL — Control, White-cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.8625