Cleared Traditional

K803243 - SEROCLUSTER FLEXIBLE VINYL U & V PL.

K803243 is the FDA 510(k) clearance for SEROCLUSTER FLEXIBLE VINYL U & V PL. by Corning Costar Corp.. It is a Class 1 Immunology device (product code JTC) cleared through the Traditional 510(k) pathway after a 36-day FDA review.

K803243 · Corning Costar Corp. · Immunology device
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Jan 1981
Decision
36d
Days
Class 1
Risk

K803243 is an FDA 510(k) clearance for the SEROCLUSTER FLEXIBLE VINYL U & V PL.. Classified as Device, Microtiter Diluting/dispensing (product code JTC), Class I - General Controls.

Submitted by Corning Costar Corp. (Mchenry, US). The FDA issued a Cleared decision on January 28, 1981 after a review of 36 days - a notably fast clearance cycle.

This device falls under the Immunology FDA review panel, regulated under 21 CFR 866.2500 - the FDA immunology 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 Corning Costar Corp. devices

Submission Details

510(k) Number K803243 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1980
Decision Date January 28, 1981
Days to Decision 36 days
Submission Type Traditional
Review Panel Immunology (IM)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
68d faster than avg
Panel avg: 104d · This submission: 36d
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 K803243.
DISPOSABLE DISPENSE MANIFOLD
K823218 · Dynatech Laboratories, Inc. · Nov 1982
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K812818 · Flow Laboratories, Inc. · Oct 1981
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MICROMEDIC REAGENT DISPENSER
K803252 · Micromedic Systems · Jan 1981
HIPPURATE DISK
K801305 · Remel Co. · Jul 1980
DYNAWASHER II
K800989 · Dynatech Laboratories, Inc. · Jun 1980