VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL)
Summary
bioMerieux, Inc. received 510(k) clearance for VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL), a LON device. Cleared on 2022-06-03.
Details
Source
510(k) Clearance
External ID
K213931
Action Date
2022-06-03
Status
Traditional
Category
device
Product Code
LON
Product Description
VITEK 2 AST-Gram Negative Omadacycline (<=0.25 - >=16 µg/mL). Product code: LON.
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 413 device clearances issued this month. bioMerieux, Inc. has received 24 total clearances in our database.
bioMerieux, Inc. has 146 FDA actions in our database, including 122 recalls and 24 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 bioMerieux, Inc. have FDA actions?
bioMerieux, Inc. has 146 FDA actions in our database, including 122 recalls and 24 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K213931" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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