510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K920337Substantially Equivalent

Miles Lipase Sera-Pak Method

Kulzer GmbH, Tarrytown NY / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K920337 is the FDA 510(k) clearance record for MILES LIPASE SERA-PAK METHOD, a class I device, cleared for Heraeus Kulzer, Inc. on under FDA product code CHI (Lipase-Esterase, Enzymatic, Photometric, Lipase). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K920337.

Clearance record

Decision date
Received
(47 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
Heraeus Kulzer, Inc. 511 Benedict Ave., Tarrytown NY
510(k) summary
Statement
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