TETRATHIONATE BROTH— 510(k) K870634

Substantially Equivalent

Hardy Media

FDA 510(k) clearance K870634 for TETRATHIONATE BROTH, Substantially Equivalent on 1987-04-14. Applicant: Hardy Media.

Clearance details

Applicant: Hardy Media
Product code: Code KZI
Advisory panel: Microbiology
Date received: 1987-02-13
Decision date: 1987-04-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Barbara, CA, 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.