510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K862233Substantially Equivalent

Ciba Corning Prisma T4 Lipia (Liposome)

Ciba Corning Diagnostics Corp., East Walpole MA / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K862233 is the FDA 510(k) clearance record for CIBA CORNING PRISMA T4 LIPIA (LIPOSOME), a class II device, cleared for Ciba Corning Diagnostics Corp. on under FDA product code KLI (Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine). FDA records list 125 510(k) clearances for Ciba Corning Diagnostics Corp., from to . As of , FDA records show no recalls naming K862233.

Clearance record

Decision date
Received
(125 days to decision)
Product code
KLI Enzyme Immunoassay, Non-Radiolabeled, Total Thyroxine
Regulation
21 CFR 862.1700
Device class
Class II
Review panel
Clinical Chemistry
Applicant
Ciba Corning Diagnostics Corp. 333 Coney St., East Walpole MA
Third party review
No

Clearances, product code KLI

Trailing 12 months

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

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