510(K) CLEARANCES 49 ▼18RECALLS POSTED 23 ▼3CLASS I 1 ▼1PMA DECISIONS 37 ▼3WEEK ENDING / FDA DATA AS OF
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K874640Substantially Equivalent

Wako(tm) Autokit Lipase

FUJIFILM Healthcare Americas Corporation, Dallas TX / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K874640 is the FDA 510(k) clearance record for WAKO(TM) AUTOKIT LIPASE, a class I device, cleared for Wako Chemicals USA, Inc. on under FDA product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase). FDA records list 394 510(k) clearances for FUJIFILM Healthcare Americas Corporation, from to . As of , FDA records show no recalls naming K874640.

Clearance record

Decision date
Received
(40 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
Wako Chemicals USA, Inc. 12300 Ford Rd., Dallas TX
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