LONZA FORMULATION R-82— 510(k) K932502

Name: FDA 510(k) clearance K932502
Creator: U.S. Food and Drug Administration
Published: 1994-05-12

Substantially Equivalent

Lonza, Inc.

FDA 510(k) clearance K932502 for LONZA FORMULATION R-82, Substantially Equivalent on 1994-05-12. Applicant: Lonza, Inc.. Device class: 1.

Clearance details

Applicant: Lonza, Inc.
Product code: Code LRJ
Device class: Class 1
Regulation: 21 CFR 880.6890
Advisory panel: General Hospital
Date received: 1993-05-12
Decision date: 1994-05-12
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fair Lawm, NJ, US

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K984485 — MICROSTAT 21999-01-13
K983947 — AMERSE 21998-12-04
K983869 — DISPATCH HOSPITAL CLEANER DISINFECTANT TOWELS WITH BLEACH1998-11-30

Adverse events under product code LRJ

product code LRJ

Injury: 958
Total: 958

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.