510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K863789Substantially Equivalent

Corning Elisa Plates

Corning Medical & Scientific, Oneonta NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K863789 is the FDA 510(k) clearance record for CORNING ELISA PLATES, a class I device, cleared for Corning Medical & Scientific on under FDA product code LIB (Device, General Purpose, Microbiology, Diagnostic). FDA records list 111 510(k) clearances for Corning Medical & Scientific, from to . As of , FDA records show no recalls naming K863789.

Clearance record

Decision date
Received
(7 days to decision)
Product code
LIB Device, General Purpose, Microbiology, Diagnostic
Regulation
21 CFR 866.2660
Device class
Class I
Review panel
Microbiology
Applicant
Corning Medical & Scientific 275 River St., Oneonta NY
Third party review
No

Clearances, product code LIB

Trailing 12 months

FDA records hold no clearances under product code LIB in the trailing twelve months.

FDA records show no clearances under product code LIB in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code LIB, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260