Cleared Traditional

OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL

K954188 · Immunotech Corp. · Hematology
Nov 1995
Decision
58d
Days
Class 2
Risk

About This 510(k) Submission

K954188 is an FDA 510(k) clearance for the OPTICLONE IGG1 FITC/IGG2A PE ISOTYPIC CONTROL, a Counter, Differential Cell (Class II — Special Controls, product code GKZ), submitted by Immunotech Corp. (Westbrook, US). The FDA issued a Cleared decision on November 3, 1995, 58 days after receiving the submission on September 6, 1995. This device falls under the Hematology review panel. Regulated under 21 CFR 864.5220.

Submission Details

510(k) Number K954188 FDA.gov
FDA Decision Cleared SESE
Date Received September 06, 1995
Decision Date November 03, 1995
Days to Decision 58 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