CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette
Summary
Hangzhou Clongene Biotech Co., Ltd. received 510(k) clearance for CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette, a NGL device. Cleared on 2024-11-08.
Details
Source
510(k) Clearance
External ID
K242802
Action Date
2024-11-08
Status
Traditional
Category
device
Product Code
NGL
Product Description
CLUNGENE Fentanyl Home Test Cassette; CLUNGENE Fentanyl Test Cassette. Product code: NGL.
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. Hangzhou Clongene Biotech Co., Ltd. has received 3 total clearances in our database.
Hangzhou Clongene Biotech Co., Ltd. has 3 FDA actions in our database, including 3 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 Hangzhou Clongene Biotech Co., Ltd. have FDA actions?
Hangzhou Clongene Biotech Co., Ltd. has 3 FDA actions in our database, including 0 recalls and 3 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K242802" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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