Cleared Traditional

K821687 - REMOVAWELL TISSUE CULTURE PLATE W/LID

K821687 is the FDA 510(k) clearance for REMOVAWELL TISSUE CULTURE PLATE W/LID by Dynatech Corp.. It is a Class 1 Microbiology device (product code KIZ) cleared through the Traditional 510(k) pathway after a 16-day FDA review.

K821687 · Dynatech Corp. · Microbiology device
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Jun 1982
Decision
16d
Days
Class 1
Risk

K821687 is an FDA 510(k) clearance for the REMOVAWELL TISSUE CULTURE PLATE W/LID. Classified as Dish, Tissue Culture (product code KIZ), Class I - General Controls.

Submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on June 24, 1982 after a review of 16 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 864.2240 - the FDA microbiology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Dynatech Corp. devices

Submission Details

510(k) Number K821687 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 08, 1982
Decision Date June 24, 1982
Days to Decision 16 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
86d faster than avg
Panel avg: 102d · This submission: 16d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KIZ Dish, Tissue Culture
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 864.2240
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.

Regulatory Peers - KIZ Dish, Tissue Culture

Devices cleared under the same product code (KIZ) and FDA review panel - the closest regulatory comparables to K821687.
MULTIWELL CULTURE PLATE INSERTS
K890542 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1989
CORNING CELL WELLS-MULTIPLE WELL PLATES
K853634 · Corning Medical & Scientific · Sep 1985
120 WELL HISTO-PLATE
K790958 · Dynatech Laboratories, Inc. · Jun 1979
PRESSURIZER, EXETER CEMENT
K781792 · Howmedica Corp. · Feb 1979