K860403

Substantially Equivalent

BIOTIS TSA WITH 5% RABBIT BLOOD

Applicant: Otisville Biotech, Inc.
Product code: JSG
Advisory panel: Microbiology
Date received: 1986-02-03
Decision date: 1986-02-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otisville, NY, US

Adverse events under product code JSG

product code JSG

Malfunction: 817
Total: 817

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.