Cleared Traditional

ABACUS 3CP

K111534 · Diatron U.S., Inc. · Hematology
Aug 2012
Decision
427d
Days
Class 2
Risk

About This 510(k) Submission

K111534 is an FDA 510(k) clearance for the ABACUS 3CP, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Diatron U.S., Inc. (Lenexa, US). The FDA issued a Cleared decision on August 2, 2012, 427 days after receiving the submission on June 2, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K111534 FDA.gov
FDA Decision Cleared SESE
Date Received June 02, 2011
Decision Date August 02, 2012
Days to Decision 427 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