Cleared Traditional

VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT

K940003 · Buckman Co., Inc. · Hematology
Oct 1995
Decision
654d
Days
Class 2
Risk

About This 510(k) Submission

K940003 is an FDA 510(k) clearance for the VOLUMET CD4 + AND CD8 + T LYMPHOCYTE COUNT TEST KIT, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Buckman Co., Inc. (Concord, US). The FDA issued a Cleared decision on October 19, 1995, 654 days after receiving the submission on January 3, 1994. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K940003 FDA.gov
FDA Decision Cleared SESE
Date Received January 03, 1994
Decision Date October 19, 1995
Days to Decision 654 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