Cleared Traditional

K872273 - CORNING EASY WASH ELISA PLATES

K872273 is an FDA 510(k) clearance for CORNING EASY WASH ELISA PLATES, manufactured by Corning Medical & Scientific. The device is a Class 1 Chemistry device with product code LIB cleared through the Traditional 510(k) pathway after a 22-day FDA review.

K872273 · Corning Medical & Scientific · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 1987
Decision
22d
Days
Class 1
Risk

K872273 is an FDA 510(k) clearance for the CORNING EASY WASH ELISA PLATES. Classified as Device, General Purpose, Microbiology, Diagnostic (product code LIB), Class I - General Controls.

Submitted by Corning Medical & Scientific (Oneonta, US). The FDA issued a Cleared decision on July 7, 1987 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 866.2660 - the FDA in vitro diagnostics and chemistry 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 Medical & Scientific devices

FDA 510(k) Submission Details - K872273

510(k) Number K872273 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 15, 1987
Decision Date July 07, 1987
Days to Decision 22 days
Submission Type Traditional
Review Panel Chemistry (CH)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
66d faster than avg
Panel avg: 88d · This submission: 22d
Pathway characteristics
Predicate-based equivalence.

LIB Device Classification - Class 1, General Controls

Product Code LIB Device, General Purpose, Microbiology, Diagnostic
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 866.2660
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 - LIB Device, General Purpose, Microbiology, Diagnostic

All 29
Devices cleared under the same product code (LIB) and FDA review panel - the closest regulatory comparables to K872273.
SUPPLEMENTARY REAGENTS FOR ENZYGNOST/TMB
K920416 · Behring Diagnostics, Inc. · Apr 1992
GULL ELISAWARE
K912558 · Gull Laboratories, Inc. · Sep 1991
NORMAL SALINE STERILE
K864249 · Mds Laboratories, Inc. · Mar 1987
CORNING ELISA PLATES
K863789 · Corning Medical & Scientific · Oct 1986
MICROSCOPE SLIDES
K862112 · Abco Dealers, Inc. · Jun 1986
MINI MASH 2000
K854602 · Dynatech Corp. · Dec 1985