Cleared Traditional

COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES

K993356 · Coulter Corp. · Hematology
Apr 2000
Decision
197d
Days
Class 2
Risk

About This 510(k) Submission

K993356 is an FDA 510(k) clearance for the COULTER HEMATOLOGY ANALYZERS WITH IRF & MRV ANALYSES, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on April 20, 2000, 197 days after receiving the submission on October 6, 1999. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K993356 FDA.gov
FDA Decision Cleared SESE
Date Received October 06, 1999
Decision Date April 20, 2000
Days to Decision 197 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220