K092819

Substantially Equivalent

REMEL SPECTRA VRE

Applicant: Thermo Fisher Scientific
Product code: JSO
Advisory panel: Microbiology
Date received: 2009-09-14
Decision date: 2010-07-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, 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.