cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems
Summary
Roche Molecular Systems, Inc. received 510(k) clearance for cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems, a QEP device. Cleared on 2026-07-08.
Details
Source
510(k) Clearance
External ID
K260917
Action Date
2026-07-08
Status
Traditional
Category
device
Product Code
QEP
Product Description
cobas CT/NG for use on the cobas 5800/6800/8800 systems; cobas TV/MG for use on the cobas 5800/6800/8800 systems. Product code: QEP.
Context & Analysis
A 510(k) clearance means the FDA determined this device is substantially equivalent to a legally marketed device. This is one of 365 device clearances issued this month. Roche Molecular Systems, Inc. has received 22 total clearances in our database.
Roche Molecular Systems, Inc. has 29 FDA actions in our database, including 7 recalls and 22 clearances.
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 Roche Molecular Systems, Inc. have FDA actions?
Roche Molecular Systems, Inc. has 29 FDA actions in our database, including 7 recalls and 22 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K260917" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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