Cleared Traditional

DIFFERENTIAL COUNTING BOARD

K915071 · Biovation, Inc. · Hematology
Jan 1992
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K915071 is an FDA 510(k) clearance for the DIFFERENTIAL COUNTING BOARD, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Biovation, Inc. (Hercules, US). The FDA issued a Cleared decision on January 17, 1992, 70 days after receiving the submission on November 8, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K915071 FDA.gov
FDA Decision Cleared SESE
Date Received November 08, 1991
Decision Date January 17, 1992
Days to Decision 70 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement

Device Classification

Product Code GKZ — Counter, Differential Cell
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.5220