SPECTRA MRSA— 510(k) K073027

Substantially Equivalent

Thermo Fisher Scientific

FDA 510(k) clearance K073027 for SPECTRA MRSA, Substantially Equivalent on 2008-02-28. Applicant: Thermo Fisher Scientific.

Clearance details

Applicant: Thermo Fisher Scientific
Product code: Code JSO
Advisory panel: Microbiology
Date received: 2007-10-26
Decision date: 2008-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

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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.