Cleared Traditional

K810719 - REPLICA PLATER

K810719 is an FDA 510(k) clearance for REPLICA PLATER, manufactured by Dynatech Corp.. The device is a Class 1 Hematology device with product code JTC cleared through the Traditional 510(k) pathway after a 15-day FDA review.

K810719 · Dynatech Corp. · Hematology device
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Apr 1981
Decision
15d
Days
Class 1
Risk

K810719 is an FDA 510(k) clearance for the REPLICA PLATER. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Dynatech Corp. (Mchenry, US). The FDA issued a Cleared decision on April 1, 1981 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 866.2500 - the FDA hematology 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

FDA 510(k) Submission Details - K810719

510(k) Number K810719 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 17, 1981
Decision Date April 01, 1981
Days to Decision 15 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
98d faster than avg
Panel avg: 113d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

JTC Device Classification - Class 1, General Controls

Product Code JTC Device, Microtiter Diluting/dispensing
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2500
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 - JTC Device, Microtiter Diluting/dispensing

All 36
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K810719.
DISPOSABLE DISPENSE MANIFOLD
K823218 · Dynatech Laboratories, Inc. · Nov 1982
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TITERTEK AUTODROP
K812818 · Flow Laboratories, Inc. · Oct 1981
AUTODILUTER III
K810659 · Dynatech Corp. · Mar 1981
SCEPTOR SYSTEM AUTOMATED MODEL 216
K810229 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1981
MIC-2000 INOCULUM TRAY LID
K810039 · Dynatech Corp. · Jan 1981