Cleared Traditional

K874598 - DYNATECH MR 250 MANUAL MICROELISA READER

K874598 is an FDA 510(k) clearance for DYNATECH MR 250 MANUAL MICROELISA READER, manufactured by Dynatech Laboratories, Inc.. The device is a Class 1 Microbiology device with product code JTC cleared through the Traditional 510(k) pathway after a 11-day FDA review.

K874598 · Dynatech Laboratories, Inc. · Microbiology device
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Nov 1987
Decision
11d
Days
Class 1
Risk

K874598 is an FDA 510(k) clearance for the DYNATECH MR 250 MANUAL MICROELISA READER. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Dynatech Laboratories, Inc. (Chantilly, US). The FDA issued a Cleared decision on November 20, 1987 after a review of 11 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.

FDA 510(k) Submission Details - K874598

510(k) Number K874598 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 09, 1987
Decision Date November 20, 1987
Days to Decision 11 days
Submission Type Traditional
Review Panel Microbiology (MI)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 102d · This submission: 11d
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 65
Devices cleared under the same product code (JTC) and FDA review panel - the closest regulatory comparables to K874598.
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WASHER 500 MICROELISA SYSTEM
K884695 · Organon Teknika Corp. · Dec 1988
BIO-TEK AUTOMATED MICROPLATE WASHER MODEL EL403
K884125 · Bio-Tek Instruments, Inc. · Dec 1988
MICROPLATE AUTO-WASHER (MOTORIZED STAGE)
K873542 · Genetic Systems Corp. · Sep 1987
MICROLAB AT
K871945 · Hamilton Co. · May 1987
CODE-A-WELL SERIES 1-1000 AND SERIES 1-1100
K863423 · Plastic Injectors, Inc. · Sep 1986
K874598 · DYNATECH MR 250 MANUAL MICROELISA READER
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