SELENITE CYSTINE BROTH— 510(k) K832533

Substantially Equivalent

Otisville Biotech, Inc.

FDA 510(k) clearance K832533 for SELENITE CYSTINE BROTH, Substantially Equivalent on 1983-10-04. Applicant: Otisville Biotech, Inc..

Clearance details

Applicant: Otisville Biotech, Inc.
Product code: Code KZI
Advisory panel: Microbiology
Date received: 1983-07-29
Decision date: 1983-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.