BIOTIS (TM) BCYE— 510(k) K874177

Substantially Equivalent

Otisville Biopharm, Inc.

FDA 510(k) clearance K874177 for BIOTIS (TM) BCYE, Substantially Equivalent on 1987-12-04. Applicant: Otisville Biopharm, Inc..

Clearance details

Applicant: Otisville Biopharm, Inc.
Product code: Code KZI
Advisory panel: Microbiology
Date received: 1987-10-15
Decision date: 1987-12-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Otisville, NY, US

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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.