Cleared Traditional

COULTER AC.T DIFF ANALYZER

K973634 · Coulter Corp. · Hematology
Oct 1997
Decision
35d
Days
Class 2
Risk

About This 510(k) Submission

K973634 is an FDA 510(k) clearance for the COULTER AC.T DIFF 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 October 29, 1997, 35 days after receiving the submission on September 24, 1997. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K973634 FDA.gov
FDA Decision Cleared SESE
Date Received September 24, 1997
Decision Date October 29, 1997
Days to Decision 35 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