Cleared Traditional

COULTER AC.T SERIES ANALYZER

K964988 · Coulter Corp. · Hematology
Mar 1997
Decision
83d
Days
Class 2
Risk

About This 510(k) Submission

K964988 is an FDA 510(k) clearance for the COULTER AC.T SERIES ANALYZER, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Corp. (Miami, US). The FDA issued a Cleared decision on March 6, 1997, 83 days after receiving the submission on December 13, 1996. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K964988 FDA.gov
FDA Decision Cleared SESE
Date Received December 13, 1996
Decision Date March 06, 1997
Days to Decision 83 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