Cleared Traditional

OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES

K950626 · Immunotech Corp. · Hematology
May 1995
Decision
84d
Days
Class 2
Risk

About This 510(k) Submission

K950626 is an FDA 510(k) clearance for the OPTICLONE CD3/CD4 MONOCLONAL ANTIBODIES, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Immunotech Corp. (Westbrook, US). The FDA issued a Cleared decision on May 5, 1995, 84 days after receiving the submission on February 10, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K950626 FDA.gov
FDA Decision Cleared SESE
Date Received February 10, 1995
Decision Date May 05, 1995
Days to Decision 84 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