Cleared Traditional

CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC

K910473 · Coulter Immunology · Hematology
Oct 1991
Decision
269d
Days
Class 2
Risk

About This 510(k) Submission

K910473 is an FDA 510(k) clearance for the CYTO-STAT(R)/COULTER CLONE(R) T11-RD1/B4-FITC, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Coulter Immunology (Hialeah, US). The FDA issued a Cleared decision on October 31, 1991, 269 days after receiving the submission on February 4, 1991. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K910473 FDA.gov
FDA Decision Cleared SESE
Date Received February 04, 1991
Decision Date October 31, 1991
Days to Decision 269 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary —

Device Classification

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