HardyCHROM CRE— 510(k) K190553

Substantially Equivalent

Hardy Diagnostics

FDA 510(k) clearance K190553 for HardyCHROM CRE, Substantially Equivalent on 2019-04-29. Applicant: Hardy Diagnostics.

Clearance details

Applicant: Hardy Diagnostics
Product code: Code JSO
Advisory panel: Microbiology
Date received: 2019-03-05
Decision date: 2019-04-29
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.