Remel Spectra ESBL— 510(k) K162620

Name: FDA 510(k) clearance K162620
Creator: U.S. Food and Drug Administration
Published: 2017-05-01

Substantially Equivalent

Remel, Inc.

FDA 510(k) clearance K162620 for Remel Spectra ESBL, Substantially Equivalent on 2017-05-01. Applicant: Remel, Inc.. Device class: 2.

Clearance details

Applicant: Remel, Inc.
Product code: Code JSO
Device class: Class 2
Regulation: 21 CFR 866.1700
Advisory panel: Microbiology
Date received: 2016-09-20
Decision date: 2017-05-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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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.