BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx
Summary
Vivachek Biotech (Hangzhou) Co., Ltd. received 510(k) clearance for BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50, a NFW device. Cleared on 2023-08-31.
Details
Source
510(k) Clearance
External ID
K231978
Action Date
2023-08-31
Status
Traditional
Category
device
Product Code
NFW
Product Description
BioSieve Marijuana Test Panel 50; BioSieve Marijuana Test Strip 50; BioSieve Dx Marijuana Test Strip 20; BioSieve Dx Marijuana Test Strip 50; BioSieve Dx Marijuana Test Panel 20; BioSieve Dx Marijuana Test Panel 50. Product code: NFW.
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. Vivachek Biotech (Hangzhou) Co., Ltd. has received 9 total clearances in our database.
Vivachek Biotech (Hangzhou) Co., Ltd. has 9 FDA actions in our database, including 9 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 Vivachek Biotech (Hangzhou) Co., Ltd. have FDA actions?
Vivachek Biotech (Hangzhou) Co., Ltd. has 9 FDA actions in our database, including 0 recalls and 9 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "K231978" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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