Product code DLI— Clinical Toxicology

SERUM CHOLINESTERASE REAGENT SET

Classification name: Acetylcholine Chloride, Specific Reagent For Pseudo Cholinesterase
Device class: Class 1
Regulation: 21 CFR 862.3240
Advisory panel: Clinical Toxicology
Total cleared: 6
First cleared: 1977-07-15
Most recent: 1995-03-15

Market context for product code DLI

FDA has cleared 6 devices under product code DLI between 1977 and 1995, filed by 6 applicant companies. No FDA device recalls reference this product code. Class I devices are low-risk and subject to FDA general controls; many Class I device types are exempt from 510(k) premarket notification.

Clearances per year

19951 clearance
19931 clearance
19862 clearances
19831 clearance
19771 clearance

Top applicants under product code DLI

Sterling Diagnostics, Inc.1 clearance
Sterling Biochemical, Inc.1 clearance
Heraeus Kulzer, Inc.1 clearance
Em Diagnostic Systems, Inc.1 clearance
E.I. Dupont DE Nemours & Co., Inc.1 clearance
American Monitor Corp.1 clearance

Recent clearances under product code DLI

Data sourced from openFDA. This site is unofficial and independent of the FDA.