IMDX FLU A/B AND RSV FOR ABBOTT M2000— 510(k) K131584

Name: FDA 510(k) clearance K131584
Creator: U.S. Food and Drug Administration
Published: 2013-08-21

Substantially Equivalent

Intelligent Medical Devices, Inc.

FDA 510(k) clearance K131584 for IMDX FLU A/B AND RSV FOR ABBOTT M2000, Substantially Equivalent on 2013-08-21. Applicant: Intelligent Medical Devices, Inc.. Device class: 2.

Clearance details

Applicant: Intelligent Medical Devices, Inc.
Product code: Code OCC
Device class: Class 2
Regulation: 21 CFR 866.3980
Advisory panel: Microbiology
Date received: 2013-05-31
Decision date: 2013-08-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Beverly, MA, US

Download summary PDF View on FDA.gov ↗

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K231017 — Panther Fusion AdV/hMPV/RV Assay2023-05-05

More clearances from Intelligent Medical Devices, Inc.

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K140198 — IMDX HSV-1/2 FOR ABBOTT M20002014-05-13
K132235 — IMDX C.DIFFICILE FOR ABBOTT M20002013-10-11
K123753 — IMDX VANR FOR ABBOTT M20002013-07-17

Adverse events under product code OCC

product code OCC

Death: 3
Malfunction: 706
Total: 709

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.