Cleared Traditional

CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE

K854724 · Lifetrac, Inc. · Pathology
Dec 1985
Decision
21d
Days
Class 1
Risk

About This 510(k) Submission

K854724 is an FDA 510(k) clearance for the CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE, a Dish, Tissue Culture (Class I — General Controls, product code KIZ), submitted by Lifetrac, Inc. (Washington, US). The FDA issued a Cleared decision on December 13, 1985, 21 days after receiving the submission on November 22, 1985. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K854724 FDA.gov
FDA Decision Cleared SESE
Date Received November 22, 1985
Decision Date December 13, 1985
Days to Decision 21 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary

Device Classification

Product Code KIZ — Dish, Tissue Culture
Device Class Class I — General Controls
CFR Regulation 21 CFR 864.2240

Similar Devices — KIZ Dish, Tissue Culture

All 7
MULTIWELL CULTURE PLATE INSERTS
K890542 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
TISSUE CULTURE DISHES
K873891 · Nunc, Inc. · Nov 1987
TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES
K871483 · Isratech Marketing Corp. · Apr 1987
CORNING CELL WELLS-MULTIPLE WELL PLATES
K853634 · Corning Medical & Scientific · Sep 1985
REMOVAWELL TISSUE CULTURE PLATE W/LID
K821687 · Dynatech Corp. · Jun 1982
120 WELL HISTO-PLATE
K790958 · Dynatech Laboratories, Inc. · Jun 1979