Cleared Traditional

MULTIWELL CULTURE PLATE INSERTS

K890542 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Pathology
Feb 1989
Decision
11d
Days
Class 1
Risk

About This 510(k) Submission

K890542 is an FDA 510(k) clearance for the MULTIWELL CULTURE PLATE INSERTS, a Dish, Tissue Culture (Class I — General Controls, product code KIZ), submitted by Bd Becton Dickinson Vacutainer Systems Preanalytic (Franklin Lakes, US). The FDA issued a Cleared decision on February 14, 1989, 11 days after receiving the submission on February 3, 1989. This device falls under the Pathology review panel. Regulated under 21 CFR 864.2240.

Submission Details

510(k) Number K890542 FDA.gov
FDA Decision Cleared SESE
Date Received February 03, 1989
Decision Date February 14, 1989
Days to Decision 11 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
TISSUE CULTURE DISHES
K873891 · Nunc, Inc. · Nov 1987
TISSUE CULTURE/BACTERIOLOGICAL PETRI DISHES
K871483 · Isratech Marketing Corp. · Apr 1987
CEKK-ADHESIVE MATRIX-MULTIPLE WELL PLATE CAM-PLATE
K854724 · Lifetrac, Inc. · Dec 1985
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