Cleared Traditional

ABACUS 5

K112755 · Diatron U.S., Inc. · Hematology
Mar 2012
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K112755 is an FDA 510(k) clearance for the ABACUS 5, 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 March 27, 2012, 188 days after receiving the submission on September 21, 2011. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K112755 FDA.gov
FDA Decision Cleared SESE
Date Received September 21, 2011
Decision Date March 27, 2012
Days to Decision 188 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