510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K862312Substantially Equivalent

Enzlipase, Enzymatic Lipase Kit

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

K862312 is the FDA 510(k) clearance record for ENZLIPASE, ENZYMATIC LIPASE KIT, a class I device, cleared for Nuclear Diagnostics, Inc. on under FDA product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase). FDA records list 24 510(k) clearances for Nuclear Diagnostics, Inc., from to . As of , FDA records show no recalls naming K862312.

Clearance record

Decision date
Received
(100 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
Nuclear Diagnostics, Inc. 3322 Commercial Ave., Northbrook IL
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