Cleared Traditional

BIOVATION K-MANAGER

K925528 · Biovation, Inc. · Hematology
Feb 1993
Decision
95d
Days
Class 2
Risk

About This 510(k) Submission

K925528 is an FDA 510(k) clearance for the BIOVATION K-MANAGER, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Biovation, Inc. (Hercules, US). The FDA issued a Cleared decision on February 5, 1993, 95 days after receiving the submission on November 2, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K925528 FDA.gov
FDA Decision Cleared SESE
Date Received November 02, 1992
Decision Date February 05, 1993
Days to Decision 95 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