Cleared Traditional

OPTICLONE CD4FITC/CD8 PE MONOCLONAL ANTIBODIES

K952789 · Immunotech Corp. · Hematology
Aug 1995
Decision
56d
Days
Class 2
Risk

About This 510(k) Submission

K952789 is an FDA 510(k) clearance for the OPTICLONE CD4FITC/CD8 PE 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 August 14, 1995, 56 days after receiving the submission on June 19, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K952789 FDA.gov
FDA Decision Cleared SESE
Date Received June 19, 1995
Decision Date August 14, 1995
Days to Decision 56 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