Cleared Traditional

K802857 - IMMULON REMOVAWELL STRIPS #011-010-6301

K802857 is the FDA 510(k) clearance for IMMULON REMOVAWELL STRIPS #011-010-6301 by Dynatech Corp.. It is a Class 1 Microbiology device (product code JTC) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K802857 · Dynatech Corp. · Microbiology device
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Dec 1980
Decision
29d
Days
Class 1
Risk

K802857 is an FDA 510(k) clearance for the IMMULON REMOVAWELL STRIPS #011-010-6301. 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 December 11, 1980 after a review of 29 days - a notably fast clearance cycle.

This device falls under the Microbiology FDA review panel, regulated under 21 CFR 866.2500 - 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 K802857 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 12, 1980
Decision Date December 11, 1980
Days to Decision 29 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
73d faster than avg
Panel avg: 102d · This submission: 29d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 30
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K802857.
TITERTEK AUTODROP
K812818 · Flow Laboratories, Inc. · Oct 1981
SCEPTOR SYSTEM AUTOMATED MODEL 216
K810229 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Feb 1981
MICROMEDIC REAGENT DISPENSER
K803252 · Micromedic Systems · Jan 1981
HIPPURATE DISK
K801305 · Remel Co. · Jul 1980
DYNAWASHER II
K800989 · Dynatech Laboratories, Inc. · Jun 1980
MIC-2000 QUAD INOCULUM TRAY
K790971 · Dynatech Laboratories, Inc. · Jun 1979