HY PBC FLASK— 510(k) K870133

Substantially Equivalent

Hy Laboratories, Ltd.

FDA 510(k) clearance K870133 for HY PBC FLASK, Substantially Equivalent on 1987-02-05. Applicant: Hy Laboratories, Ltd..

Clearance details

Applicant: Hy Laboratories, Ltd.
Product code: Code JSG
Advisory panel: Microbiology
Date received: 1987-01-12
Decision date: 1987-02-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Rehovot 76326, IL

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.