510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K897150Substantially Equivalent

Lipase Color [Toyo] Serum Lipase Test Kit

Toyo Jozo Co., Ltd., Washington DC / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K897150 is the FDA 510(k) clearance record for LIPASE COLOR [TOYO] SERUM LIPASE TEST KIT, a class I device, cleared for Toyo Jozo Co., Ltd. on under FDA product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase). FDA records list one 510(k) clearance for Toyo Jozo Co., Ltd. As of , FDA records show 4 recalls naming K897150.

Clearance record

Decision date
Received
(62 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
Toyo Jozo Co., Ltd. Intl. Sq., Washington DC
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