BHI WITH SHEEP BLOOD (5%)— 510(k) K870639

Substantially Equivalent

Hardy Media

FDA 510(k) clearance K870639 for BHI WITH SHEEP BLOOD (5%), Substantially Equivalent on 1987-04-14. Applicant: Hardy Media.

Clearance details

Applicant: Hardy Media
Product code: Code JSG
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 JSG

product code JSG

Malfunction: 817
Total: 817

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.