510(k) K862400— BIOTIS KV LAKED BLOOD AGAR

Substantially Equivalent

Otisville Biotech, Inc.

Clearance details

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

Adverse events under product code JSJ

product code JSJ

Malfunction: 520
Total: 520

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.