Cleared Traditional

MULTI-CENTRIFUGE

K955795 · Novonx, Inc. · Hematology

Mar 1996

Decision

98d

Days

Class 2

Risk

About This 510(k) Submission

K955795 is an FDA 510(k) clearance for the MULTI-CENTRIFUGE, a Centrifuge, Hematocrit (Class II — Special Controls, product code GKG), submitted by Novonx, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 29, 1996, 98 days after receiving the submission on December 22, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.6400.

Submission Details

510(k) Number	K955795 FDA.gov
FDA Decision	Cleared SESE
Date Received	December 22, 1995
Decision Date	March 29, 1996
Days to Decision	98 days
Submission Type	Traditional
Review Panel	Hematology (HE)
Summary	Summary PDF