Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection
Summary
Rheonix, Inc. received 510(k) clearance for Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit, a QEP device. Cleared on 2021-12-17.
Details
Source
510(k) Clearance
External ID
K193081
Action Date
2021-12-17
Status
Traditional
Category
device
Product Code
QEP
Product Description
Rheonix STI TriPlex Assay, Rheonix EncompassMDx Workstation (instrument and software), Rheonix Urine Specimen Collection Kit. Product code: QEP.
Company
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 403 device clearances issued this month.
Frequently Asked Questions
What does 510(k) clearance mean?
A 510(k) is an FDA premarket submission demonstrating that a device is substantially equivalent to a legally marketed device. It does NOT mean FDA approval — it means the device is cleared for marketing because it's similar enough to an existing cleared device. Most medical devices reach market via 510(k) rather than full PMA approval.
How often does Rheonix, Inc. have FDA actions?
This is the only FDA action we have on record for Rheonix, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K193081" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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