510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K823860Substantially Equivalent

Nuclipase (I125) Pancreatic Lipase

Nuclear Diagnostics, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K823860 is the FDA 510(k) clearance record for NUCLIPASE (I125) PANCREATIC LIPASE, a class I device, cleared for Nuclear Diagnostics, Inc. on under FDA product code CET (Olive Oil Emulsion (Turbidimetric), Lipase). FDA records list 24 510(k) clearances for Nuclear Diagnostics, Inc., from to . As of , FDA records show no recalls naming K823860.

Clearance record

Decision date
Received
(117 days to decision)
Product code
CET Olive Oil Emulsion (Turbidimetric), Lipase
Regulation
21 CFR 862.1465
Device class
Class I
Review panel
Clinical Chemistry
Applicant
Nuclear Diagnostics, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code CET

Trailing 12 months

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

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