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

Name: FDA 510(k) clearance K951754
Creator: U.S. Food and Drug Administration
Published: 1995-10-16

Substantially Equivalent

Hardy Diagnostics

FDA 510(k) clearance K951754 for CULTURE MEDIA, ANTIMICROBIAL SUSCEPTIBILITY TEST, Substantially Equivalent on 1995-10-16. Applicant: Hardy Diagnostics. Device class: 2.

Clearance details

Applicant: Hardy Diagnostics
Product code: Code JSO
Device class: Class 2
Regulation: 21 CFR 866.1700
Advisory panel: Microbiology
Date received: 1995-04-17
Decision date: 1995-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Maria, CA, US

Download summary PDF View on FDA.gov ↗

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K171061 — MRSASelect II2017-12-28
K162620 — Remel Spectra ESBL2017-05-01
K160512 — HardyCHROM ESBL2016-11-15

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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.