Cleared Traditional

K790958 - 120 WELL HISTO-PLATE

K790958 is an FDA 510(k) clearance for 120 WELL HISTO-PLATE, manufactured by Dynatech Laboratories, Inc.. The device is a Class 1 Pathology device with product code KIZ cleared through the Traditional 510(k) pathway after a 37-day FDA review.

K790958 · Dynatech Laboratories, Inc. · Pathology device
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Jun 1979
Decision
37d
Days
Class 1
Risk

K790958 is an FDA 510(k) clearance for the 120 WELL HISTO-PLATE. Classified as Dish, Tissue Culture (product code KIZ), Class I - General Controls.

Submitted by Dynatech Laboratories, Inc. (Mchenry, US). The FDA issued a Cleared decision on June 28, 1979 after a review of 37 days - a notably fast clearance cycle.

This device falls under the Pathology FDA review panel, regulated under 21 CFR 864.2240 - the FDA pathology 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 Laboratories, Inc. devices

FDA 510(k) Submission Details - K790958

510(k) Number K790958 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 22, 1979
Decision Date June 28, 1979
Days to Decision 37 days
Submission Type Traditional
Review Panel Pathology (PA)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
40d faster than avg
Panel avg: 77d · This submission: 37d
Pathway characteristics
Predicate-based equivalence.

KIZ Device Classification - Class 1, General Controls

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 K790958.
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
REMOVAWELL TISSUE CULTURE PLATE W/LID
K821687 · Dynatech Corp. · Jun 1982
PRESSURIZER, EXETER CEMENT
K781792 · Howmedica Corp. · Feb 1979