HARDYCHROM MRSA— 510(k) K102922

Substantially Equivalent

Hardy Diagnostics

FDA 510(k) clearance K102922 for HARDYCHROM MRSA, Substantially Equivalent on 2011-05-04. Applicant: Hardy Diagnostics.

Clearance details

Applicant: Hardy Diagnostics
Product code: Code JSO
Advisory panel: Microbiology
Date received: 2010-10-01
Decision date: 2011-05-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

Download summary PDF View on FDA.gov ↗

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.