510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K952816Substantially Equivalent

Lipase Flex Reagent Cartridge

Dupont Medical Products, Wilmington DE / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K952816 is the FDA 510(k) clearance record for LIPASE FLEX REAGENT CARTRIDGE, a class I device, cleared for Dupont Medical Products on under FDA product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase). FDA records list 28 510(k) clearances for Dupont Medical Products, from to . As of , FDA records show 3 recalls naming K952816.

Clearance record

Decision date
Received
(30 days to decision)
Product code
CHI Lipase-Esterase, Enzymatic, Photometric, Lipase
Regulation
21 CFR 862.1465
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Dupont Medical Products Barley Mill Plz., Wilmington DE
510(k) summary
Summary
Third party review
No

Clearances, product code CHI

Trailing 12 months

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

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