510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K803244Substantially Equivalent

Assay Strips

Corning Costar Corp., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K803244 is the FDA 510(k) clearance record for ASSAY STRIPS, a class I device, cleared for Corning Costar Corp. on under FDA product code JTC (Device, Microtiter Diluting/Dispensing). FDA records list 8 510(k) clearances for Corning Costar Corp., from to . As of , FDA records show no recalls naming K803244.

Clearance record

Decision date
Received
(41 days to decision)
Product code
JTC Device, Microtiter Diluting/Dispensing
Regulation
21 CFR 866.2500
Device class
Class I
Review panel
Microbiology
Applicant
Corning Costar Corp. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code JTC

Trailing 12 months

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

FDA records show no clearances under product code JTC in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code JTC, 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