510(k) K951754— CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST

Substantially Equivalent

Hardy Diagnostics

Clearance details

Applicant: Hardy Diagnostics
Product code: Code JSO
Advisory panel: Microbiology
Date received: 1995-04-17
Decision date: 1995-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

Adverse events under product code JSO

product code JSO

Malfunction: 602
Total: 602

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.