Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0
Summary
Genalyte, Inc. received 510(k) clearance for Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0, a JLW device. Cleared on 2024-07-22.
Details
Source
510(k) Clearance
External ID
K234091
Action Date
2024-07-22
Status
Traditional
Category
device
Product Code
JLW
Product Description
Maverick Diagnostic System TC1000; Maverick Test Panel A0.B0. Product code: JLW.
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 Genalyte, Inc. have FDA actions?
This is the only FDA action we have on record for Genalyte, Inc. in our database.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K234091" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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