KLEEN TEST O.R. KIT— 510(k) K890098

Substantially Equivalent

Kleen Test Products

FDA 510(k) clearance K890098 for KLEEN TEST O.R. KIT, Substantially Equivalent on 1989-01-24. Applicant: Kleen Test Products.

Clearance details

Applicant: Kleen Test Products
Product code: Code LRO
Advisory panel: General, Plastic Surgery
Date received: 1989-01-10
Decision date: 1989-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Elkhorn, WI, US

Download summary PDF View on FDA.gov ↗

Adverse events under product code LRO

product code LRO

Injury: 975
Malfunction: 14,038
Other: 2
Total: 15,015

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.