Cleared Traditional

SPUNCRIT

K925863 · bioMerieux, Inc. · Hematology
Feb 1993
Decision
78d
Days
Class 2
Risk

About This 510(k) Submission

K925863 is an FDA 510(k) clearance for the SPUNCRIT, a Centrifuge, Hematocrit (Class II — Special Controls, product code GKG), submitted by bioMerieux, Inc. (Bethlehem, US). The FDA issued a Cleared decision on February 5, 1993, 78 days after receiving the submission on November 19, 1992. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number K925863 FDA.gov
FDA Decision Cleared SESE
Date Received November 19, 1992
Decision Date February 05, 1993
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF

Device Classification

Product Code GKG — Centrifuge, Hematocrit
Device Class Class II — Special Controls
CFR Regulation 21 CFR 864.6400