BIOTIS BORDET GENGOU AGAR— 510(k) K862390

Substantially Equivalent

Otisville Biotech, Inc.

FDA 510(k) clearance K862390 for BIOTIS BORDET GENGOU AGAR, Substantially Equivalent on 1986-07-03. Applicant: Otisville Biotech, Inc..

Clearance details

Applicant: Otisville Biotech, Inc.
Product code: Code KZI
Advisory panel: Microbiology
Date received: 1986-06-24
Decision date: 1986-07-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otisville, NY, 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.