510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K874584Substantially Equivalent

Triglyerides Test Kit

Ciba Corning Diagnostics Corp., Oberlin OH / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874584 is the FDA 510(k) clearance record for TRIGLYERIDES TEST KIT, a class I device, cleared for Ciba Corning Diagnostics Corp. on under FDA product code CDT (Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides). FDA records list 125 510(k) clearances for Ciba Corning Diagnostics Corp., from to . As of , FDA records show no recalls naming K874584.

Clearance record

Decision date
Received
(73 days to decision)
Product code
CDT Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides
Regulation
21 CFR 862.1705
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Ciba Corning Diagnostics Corp. Gilford Systems, Oberlin OH
Third party review
No

Clearances, product code CDT

Trailing 12 months

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

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