K853236

Substantially Equivalent

APL TSA WITH 5% SHEEP BLOOD

Applicant: Apl Medical Supplies
Product code: KZI
Advisory panel: Microbiology
Date received: 1985-08-01
Decision date: 1985-08-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

Adverse events under product code KZI

product code KZI

Malfunction: 2,834
Total: 2,834

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.