DU PONT LINX HD-25 LASR IMAGER— 510(k) K923042

Name: FDA 510(k) clearance K923042
Creator: U.S. Food and Drug Administration
Published: 1992-11-09

Substantially Equivalent

E.I. Dupont DE Nemours & Co., Inc.

FDA 510(k) clearance K923042 for DU PONT LINX HD-25 LASR IMAGER, Substantially Equivalent on 1992-11-09. Applicant: E.I. Dupont DE Nemours & Co., Inc.. Device class: 2.

Clearance details

Applicant: E.I. Dupont DE Nemours & Co., Inc.
Product code: Code LLZ
Device class: Class 2
Regulation: 21 CFR 892.2050
Advisory panel: Radiology
Date received: 1992-06-24
Decision date: 1992-11-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wilmington, DE, US

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K953725 — CRONEX RADIATION THERAPY VERIFICATION CASSETTE1995-09-06
K951441 — DUPONT ACA DIGOXIN (DGN A) METHOD1995-06-01
K950137 — URINE BARBITURATES SCREEN FLEX(TM) REAGENT CARTRIDGE1995-04-13

Adverse events under product code LLZ

product code LLZ

Death: 13
Total: 13

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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