510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K930208Substantially Equivalent

Cholinesterase Method for Technicon Chem1/technico

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

K930208 is the FDA 510(k) clearance record for CHOLINESTERASE METHOD FOR TECHNICON CHEM1/TECHNICO, a class I device, cleared for Heraeus Kulzer, Inc. on under FDA product code DLI (Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase). FDA records list 205 510(k) clearances for KULZER GMBH, from to . As of , FDA records show no recalls naming K930208.

Clearance record

Decision date
Received
(95 days to decision)
Product code
DLI Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
Regulation
21 CFR 862.3240
Device class
Class I
Review panel
Clinical Toxicology
Applicant
Heraeus Kulzer, Inc. 511 Benedict Ave., Tarrytown NY
510(k) summary
Summary
Third party review
No

Clearances, product code DLI

Trailing 12 months

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

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