APL TSA WITH 5% SHEEP BLOOD— 510(k) K853236

Substantially Equivalent

Apl Medical Supplies

FDA 510(k) clearance K853236 for APL TSA WITH 5% SHEEP BLOOD, Substantially Equivalent on 1985-08-19. Applicant: Apl Medical Supplies.

Clearance details

Applicant: Apl Medical Supplies
Product code: 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

Download summary PDF View on FDA.gov ↗

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.